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DINAMAP ®<br />

<strong>ProCare</strong> Monitor<br />

Operation Manual


Contents<br />

Introduction<br />

Reissues and Updates...................................................................................................................... 3<br />

Errors and Omissions ....................................................................................................................... 3<br />

Hierarchy of Warnings and Cautions........................................................................................... 4<br />

About the DINAMAP ® <strong>ProCare</strong> Monitor .....................................................................................7<br />

Product Compliance ......................................................................................................................10<br />

Symbols ............................................................................................................................................11<br />

Getting Started<br />

Unpacking the Monitor and Accessories ..................................................................................15<br />

Setting up BP Connections ...........................................................................................................15<br />

Setting up SpO 2 Connections .....................................................................................................16<br />

Setting up Temperature Connections ........................................................................................16<br />

Setting up the Printer (Installing the Paper) ...............................................................................17<br />

Power Sources..................................................................................................................................17<br />

Powering the Monitor: Battery and DC Supply .......................................................................17<br />

Replacing the Battery .....................................................................................................................19<br />

Switching the Monitor On and Off ............................................................................................20<br />

Setting the Date and Time ............................................................................................................20<br />

Product Overview<br />

Buttons ..............................................................................................................................................25<br />

Front Panel ...................................................................................................................................... 27<br />

Rear Panel ........................................................................................................................................29<br />

Left-Side Panel .................................................................................................................................30<br />

Right-Side Panel ..............................................................................................................................30<br />

Windows.......................................................................................................................................... 31<br />

Indicators ..........................................................................................................................................31<br />

Operating Modes ...........................................................................................................................31<br />

Entering Configuration Mode ...................................................................................31<br />

Parameter Modes ...........................................................................................................................32<br />

User Modes .................................................................................................................................... 32<br />

Sounds ..............................................................................................................................................33<br />

Power Sources ................................................................................................................................34<br />

Specifications ...................................................................................................................................35<br />

Mechanical ...................................................................................................................35<br />

Power Requirements ................................................................................................. 35<br />

Environmental ...............................................................................................................36<br />

Printer<br />

Description .......................................................................................................................................41<br />

Installing the Paper .........................................................................................................................41<br />

Print Button ......................................................................................................................................41<br />

Printer Alarms ...................................................................................................................................42<br />

Storage ............................................................................................................................................. 42<br />

Alarms<br />

Alarm Codes ....................................................................................................................................45<br />

Adjusting Alarm Limits.................................................................................................................. 45<br />

Alarms Button ..............................................................................................................45


Adjusting the Alarm Volume ....................................................................................................... 46<br />

Silencing and Acknowledging an Alarm ....................................................................................46<br />

Silence Button............................................................................................................. 46<br />

Alarm Sounds ..................................................................................................................................46<br />

Alarm Detection and Priorities ....................................................................................................47<br />

Limit Alarms ..................................................................................................................47<br />

Parameter Status Alarms ............................................................................................48<br />

Printer Alarms ..............................................................................................................48<br />

Battery Alarms ..............................................................................................................48<br />

Memory Alarms ...........................................................................................................48<br />

System Failure Alarms ................................................................................................48<br />

Specifications ...................................................................................................................................49<br />

Alarm Message Codes ...................................................................................................................50<br />

History<br />

Description...................................................................................................................................... 55<br />

Buttons Associated with History .................................................................................................55<br />

Erasing Stored History.................................................................................................55<br />

Windows Associated with History...............................................................................................56<br />

Indicators Associated with History ............................................................................................ 56<br />

BP<br />

Description...................................................................................................................................... 59<br />

Buttons Associated with BP ..........................................................................................................62<br />

Windows Associated with BP ......................................................................................................62<br />

Indicators Associated with BP.......................................................................................................63<br />

Parameter Modes ............................................................................................................................63<br />

BP Modes of Operation ............................................................................................................... 64<br />

Manual BP Determinations .......................................................................................64<br />

Auto Cycle Determinations ......................................................................................64<br />

STAT BP Determinations ...........................................................................................65<br />

User Settings................................................................................................................................... 66<br />

Mode Settings...............................................................................................................66<br />

Limit Settings ............................................................................................................... 66<br />

Neonate Settings.............................................................................................66<br />

Menu Settings .................................................................................................................................67<br />

Sounds Associated with B..............................................................................................................67<br />

Procedures .......................................................................................................................................67<br />

Cuff Connections ........................................................................................................69<br />

Quick-Disconnect Air Hose ........................................................................ 69<br />

Neonate Air Hose ..........................................................................................69<br />

Alarms .............................................................................................................................................. 70<br />

Critikon US Patents .....................................................................................................70<br />

European US Patents ..................................................................................................70<br />

Specifications ...................................................................................................................................71<br />

Factory Default Settings .............................................................................................71<br />

SpO 2<br />

NELLCOR ® SpO 2 ............................................................................................................................75<br />

Description .......................................................................................................................................75


Contents<br />

Configuration Settings Associated with SpO 2 ..........................................................................77<br />

Buttons Associated with SpO 2 .....................................................................................................78<br />

Windows Associated with SpO 2 .................................................................................................78<br />

Indicators Associated with SpO 2 ................................................................................................78<br />

Parameter Modes ...........................................................................................................................78<br />

User Settings ....................................................................................................................................79<br />

Limit settings................................................................................................................ 79<br />

Menu Settings .................................................................................................................................79<br />

Sounds Associated with SpO 2......................................................................................................79<br />

Procedures .......................................................................................................................................79<br />

Alarms ...............................................................................................................................................81<br />

Troubleshooting.......................................................................................................... 82<br />

Specifications ...................................................................................................................................85<br />

Measurement Range ..................................................................................................85<br />

Accuracy and Motion Tolerance .............................................................................85<br />

Saturation .........................................................................................................85<br />

Pulse Rate ........................................................................................................85<br />

NELLCOR ® Sensor Accuracy................................................................................... 85<br />

OxiMAX........................................................................................................... 85<br />

OxiCliq .............................................................................................................85<br />

Reusable Sensor Models ...............................................................................86<br />

Factory Default Settings..............................................................................................86<br />

NELLCOR ® Patents .....................................................................................................86<br />

Masimo Set ® SpO 2 ........................................................................................................................ 89<br />

Description .......................................................................................................................................89<br />

Configuration Settings Associated with SpO 2 ..........................................................................92<br />

Buttons Associated with SpO 2 ....................................................................................................93<br />

Windows Associated with SpO 2 .................................................................................................93<br />

Indicators Associated with SpO 2 ................................................................................................93<br />

Parameter Modes ...........................................................................................................................93<br />

User Settings ....................................................................................................................................94<br />

Limit settings ................................................................................................................94<br />

Menu Settings .................................................................................................................................94<br />

Sounds Associated with SpO 2.................................................................................................... 94<br />

Procedures ........................................................................................................................................94<br />

Alarms ...............................................................................................................................................96<br />

Troubleshooting ..........................................................................................................97<br />

Specifications ................................................................................................................................ 100<br />

Measurement Range ............................................................................................... 100<br />

Accuracy and Motion Tolerance .......................................................................... 100<br />

Saturation ...................................................................................................... 100<br />

Pulse Rate ..................................................................................................... 100<br />

Masimo ® Sensor Accuracy ........................................................................ 101<br />

Resolution ..................................................................................................... 101<br />

Low Perfusion Performance....................................................................... 101<br />

Interfering Substances............................................................................................. 101<br />

Sensor Light Source ................................................................................................. 101<br />

Factory Default Settings.......................................................................................... 102<br />

Masimo ® Patents ...................................................................................................... 102


TURBOTEMP<br />

Description .................................................................................................................................... 105<br />

Predictive Mode ....................................................................................................... 105<br />

Monitor Mode .......................................................................................................... 106<br />

Configuration Settings Associated with Temperature .......................................................... 107<br />

Buttons Associated with Temperature .................................................................................... 107<br />

Windows Associated with Temperature ................................................................................ 107<br />

Indicators Associated with Temperature ................................................................................. 107<br />

Measurement in Progress Indicators ................................................................... 107<br />

Predictive Mode .......................................................................................... 107<br />

Measurement NOT in Progress Indicators ......................................................... 108<br />

Parameter Modes ........................................................................................................................ 108<br />

User Settings................................................................................................................................. 109<br />

Menu Settings .............................................................................................................................. 109<br />

Sounds Associated with TURBO´TEMP ............................................................................. 109<br />

Procedures for Oral Predictive Mode Determinations ....................................................... 109<br />

Procedures for Rectal Predictive Mode Determinations .................................................... 110<br />

Procedures for Monitor Mode Determinations (Axillary Determinations) ..................... 110<br />

Alarms ............................................................................................................................................ 113<br />

Specifications ................................................................................................................................ 115<br />

Factory Default Settings .......................................................................................... 115<br />

IVAC ® Patents .............................................................................................................................. 115<br />

Pulse Rate<br />

Description .................................................................................................................................... 119<br />

General Notes .............................................................................................................................. 119<br />

Buttons Associated with Pulse Rate ........................................................................................ 119<br />

Windows Associated with Pulse Rate ..................................................................................... 120<br />

Indicators Associated with Pulse Rate .................................................................................... 120<br />

Parameter Modes ......................................................................................................................... 120<br />

User Settings................................................................................................................................. 120<br />

Limit settings ............................................................................................................. 120<br />

Menu Settings .............................................................................................................................. 120<br />

Sounds Associated with Pulse Rate ......................................................................................... 120<br />

Alarms ............................................................................................................................................. 121<br />

Specifications ................................................................................................................................ 122<br />

Factory Default Settings .......................................................................................... 122<br />

Appendix A: Principles of Noninvasive Blood Pressure Determination<br />

Principles of Noninvasive Blood Pressure Determination .................................................. 125<br />

Systolic Search .......................................................................................................... 126<br />

Reference Used to Determine NIBP Accuracy ................................................. 127<br />

DINAMAP Monitors With Intra-Arterial Reference<br />

(DINAMAP Classic Technology).............................................................. 127<br />

DINAMAP Monitors With Auscultatory Reference<br />

(DINAMAP Auscultatory Technology) ................................................... 127<br />

Appendix B: Maintenance<br />

Maintenance.................................................................................................................................. 131<br />

Cleaning the Monitor .............................................................................................. 131


Contents<br />

Cuff Cleaning and Disinfection ............................................................................. 131<br />

General .......................................................................................................... 131<br />

Materials ........................................................................................................ 131<br />

Procedure ..................................................................................................... 132<br />

Temperature Devices .............................................................................................. 132<br />

SpO 2 Sensors ............................................................................................................ 132<br />

Storage and Battery Care ........................................................................................................... 133<br />

Fuses ............................................................................................................................................... 133<br />

Calibration ..................................................................................................................................... 133<br />

Leak Testing .................................................................................................................................. 133<br />

Disposal of Product Waste ........................................................................................................ 135<br />

Batteries ......................................................................................................................135<br />

Patient Applied Parts ............................................................................................... 135<br />

Packaging Material .................................................................................................. 135<br />

Appendix C: Connection Details<br />

Connection Details ..................................................................................................................... 139<br />

Host Port Connector (rear panel) ......................................................................... 139<br />

Appendix D: Warranty, Service, & Spare Parts<br />

Warranty, Service, and Spare Parts.......................................................................................... 143<br />

Warranty ........................................................................................................................................ 143<br />

Assistance and Parts .................................................................................................................... 143<br />

Repairs ........................................................................................................................................... 144<br />

Packing Instructions .................................................................................................................... 144<br />

Service Manuals........................................................................................................................... 144<br />

Appendix E: Reorder Codes<br />

Reorder Codes ............................................................................................................................. 147


DINAMAP ®<br />

<strong>ProCare</strong> Monitor<br />

Operation Manual<br />

1


DINAMAP ® <strong>ProCare</strong> Monitor<br />

2


DINAMAP ® <strong>ProCare</strong> Monitor<br />

Operation Manual<br />

This manual is for DINAMAP <strong>ProCare</strong> Monitors models 100,<br />

200, 300, and 400, with or without printers.<br />

• <strong>ProCare</strong> 100: BP, Pulse<br />

• <strong>ProCare</strong> 200: BP, Pulse, and Temp<br />

• <strong>ProCare</strong> 300: BP, Pulse, and SpO2 • <strong>ProCare</strong> 400: BP, Pulse, Temp, and SpO2 The model of the Monitor determines which parameters are<br />

in your monitor. Please refer to applicable sections.<br />

Reissues and Updates<br />

Changes occurring between issues are addressed through<br />

Change Information Sheets, Addendums, and replacement<br />

pages. If a Change Information Sheet does not accompany<br />

this manual, it is correct as printed.<br />

Errors and Omissions<br />

If errors or omissions are found in this manual, please notify:<br />

GE <strong>Medical</strong> Systems Information Technologies<br />

Technical Publications<br />

4502 Woodland Corporate Boulevard<br />

Tampa, FL 33614<br />

1-877-274-8456<br />

Part No. 2009360-001 B<br />

The content of this document including all figures and<br />

drawings is proprietary information of GE <strong>Medical</strong> Systems<br />

Information Technologies, provided solely for purposes of<br />

operation, maintenance or repair, and dissemination for<br />

other purposes or copying thereof is prohibited without prior<br />

written consent by GE <strong>Medical</strong> Systems Information<br />

Technologies, Tampa, Florida.<br />

Illustrations may show design models; production units may<br />

incorporate changes.<br />

3


Hierarchy of Warnings and Cautions<br />

A general warning is a statement that alerts the user to the<br />

possibility of injury, death, or other serious adverse reactions<br />

associated with the misuse of the device. A warning relates<br />

to steps in a procedure.<br />

A general caution is a statement that alerts the user to the<br />

possibility of a problem with the device associated with its<br />

use or misuse. Such problems include device malfunction,<br />

device failure, damage to the device or damage to other<br />

property. A caution relates to steps in a procedure.<br />

© GE <strong>Medical</strong> Systems Information Technologies 2002. All<br />

rights reserved. TAMPA, FL 33614<br />

Printed in the U.S.A. All rights reserved.<br />

United States<br />

GE <strong>Medical</strong> Systems Information Technologies<br />

4502 Woodland Corporate Boulevard<br />

Tampa, FL 33614<br />

European Representative<br />

GE <strong>Medical</strong> Systems<br />

Information Technologies GmbH<br />

Postfach 60 02 65<br />

D-79032 Freiburg, Germany<br />

Tel. +49 761 45 43 - 0<br />

Fax +49 761 45 43 - 233<br />

4


Introduction


About the DINAMAP ® <strong>ProCare</strong> Monitor<br />

The <strong>ProCare</strong> Monitor provides a small, portable, easy-to-use<br />

monitoring alternative for sub-acute hospital and nonhospital<br />

settings. The battery-operated Monitor offers<br />

noninvasive determination of systolic blood pressure,<br />

diastolic blood pressure, mean arterial pressure, pulse rate,<br />

oxygen saturation, and temperature. Monitors are available<br />

with or without integrated printers. <strong>ProCare</strong> Monitors are<br />

intended for use in various markets, from the physician’s<br />

office to sub-acute triage and medical/surgical units.<br />

• <strong>ProCare</strong> 100: BP, Pulse<br />

• <strong>ProCare</strong> 200: BP, Pulse, and Temp<br />

• <strong>ProCare</strong> 300: BP, Pulse, and SpO2 • <strong>ProCare</strong> 400: BP, Pulse, Temp, and SpO2 The model of the Monitor determines which parameters are<br />

in your monitor. Please refer to applicable sections.<br />

Using the <strong>ProCare</strong> Monitor, a clinician can view, print, and<br />

recall clinical data that is derived from each parameter. The<br />

Monitor is also capable of alerting the clinician to changes in<br />

the patient’s condition or when it is unable to effectively<br />

monitor the patient’s condition. All of the main operations of<br />

the <strong>ProCare</strong> Monitor are easy-to-use and only a button-touch<br />

away. Please review the factory default settings and, where<br />

applicable, enter settings appropriate for your use.<br />

Indications<br />

The <strong>ProCare</strong> Monitor is intended to monitor one patient at a<br />

time in a clinical setting.<br />

Contraindications<br />

This device is not designed, sold, or intended for use except<br />

as indicated.<br />

Federal law (U.S.A.) restricts this device to sale by or on the<br />

order of a clinician.<br />

7<br />

Introduction


Warnings<br />

• Do not use the <strong>ProCare</strong> Monitor in the presence of<br />

magnetic resonance imaging (MRI) devices. There have<br />

been reports of sensors causing patient burns when<br />

operating in an MRI environment.<br />

• Do not use the Monitor in the presence of flammable<br />

anesthetics.<br />

• To help prevent unintended current return paths with<br />

the use of high frequency (HF) surgical equipment,<br />

ensure that the HF surgical neutral electrode is<br />

properly connected.<br />

• To avoid personal injury, do not perform any servicing<br />

unless qualified to do so.<br />

• WARNING: These Monitors should not be used on<br />

patients who are connected to cardiopulmonary bypass<br />

machines.<br />

• If powering the Monitor from an external power<br />

adapter or converter, use only GE <strong>Medical</strong> Systems<br />

Information Technologies-approved power adapters<br />

and converters.<br />

• The Monitor does not include any user-replaceable<br />

fuses. Refer servicing to qualified service personnel.<br />

• To reduce the risk of electric shock, do not remove the<br />

cover or the back. Refer servicing to a qualified service<br />

person.<br />

• If the accuracy of any determination reading is<br />

questionable, first check the patient’s vital signs by<br />

alternate means and then check the <strong>ProCare</strong> Monitor<br />

for proper functioning.<br />

Cautions<br />

• Do not use replacement batteries other than the type<br />

supplied with the Monitor. Replacement batteries are<br />

available from GE <strong>Medical</strong> Systems - Accessories and<br />

Supplies.<br />

•The <strong>ProCare</strong> Monitor is designed to conform to<br />

Electromagnetic Compatibility (EMC) standard IEC<br />

601-1-2, 1993 and will operate accurately in<br />

8


conjunction with other medical equipment which also<br />

meets this requirement. To avoid interference problems<br />

affecting the Monitor, do not use the Monitor in the<br />

presence of equipment which does not conform to<br />

these specifications.<br />

• Place the <strong>ProCare</strong> Monitor on a rigid, secure surface.<br />

Monitor must only be used with mounting hardware,<br />

poles, and stands recommended by GE <strong>Medical</strong><br />

Systems Information Technologies.<br />

• The weight of the accessory basket contents should not<br />

exceed 5 lb (2.7kg).<br />

• Arrange the external AC/DC power converter, air<br />

hoses, and all cables carefully so they do not constitute<br />

a hazard.<br />

• Verify calibration of BP parameter (temp and pulse<br />

oximeter do not require calibration). Ensure that the<br />

display is functioning properly before operating the<br />

<strong>ProCare</strong> Monitor.<br />

• Do not immerse the Monitor in water. If the Monitor is<br />

splashed with water or becomes wet, wipe it<br />

immediately with a dry cloth.<br />

• Do not gas sterilize or autoclave.<br />

•The <strong>ProCare</strong> Monitor, when used with GE <strong>Medical</strong><br />

Systems Information Technologies-approved applied<br />

parts and accessories, is protected against defibrillator<br />

damage.<br />

Note<br />

• The electromagnetic compatibility profile of the <strong>ProCare</strong><br />

Monitor may change if accessories other than those<br />

specified for use with the <strong>ProCare</strong> Monitor are used.<br />

9<br />

Introduction


Product Compliance<br />

The DINAMAP ® <strong>ProCare</strong> Monitor is classified in the following<br />

categories for compliance with IEC 601-1:<br />

• Internally powered or Class II when powered from<br />

external supply<br />

•Transportable<br />

• For continuous operation<br />

• Not suitable for use in the presence of flammable anesthetics<br />

• Not for use in the presence of an oxygen-enriched<br />

atmosphere (oxygen tent)<br />

• Type BF applied parts<br />

• IPX1, degree of protection against ingress of water<br />

• Sterilization/Disinfection, see Appendix B<br />

• Software is developed in accordance with IEC 601-1-4.<br />

• This equipment is suitable for connection to public<br />

mains via power adaptors as defined in CISPR 11.<br />

•The SpO2 parameter conforms to EN 865:1997 with<br />

the exception of Clauses 36, 48, sub-clause<br />

51.108.1and to ISO 9919.<br />

• Defibrillation protected. When used with the<br />

recommended accessories, the Monitor is protected<br />

against the effects of defibrillator discharge. If<br />

monitoring is disrupted by the defibrillation, the<br />

Monitor will recover.<br />

0086<br />

DINAMAP ® PROCARE MONITOR<br />

CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE<br />

AND MECHANICAL AND OTHER SPECIFIED HAZARDS<br />

ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.<br />

601.1. ALSO EVALUATED TO IEC-601-2-30.<br />

This product conforms with the essential requirements<br />

of the <strong>Medical</strong> Device Directive. Accessories without<br />

the CE mark are not guaranteed to meet the Essential<br />

Requirements of the <strong>Medical</strong> Device Directive.<br />

10


Symbols<br />

The following symbols are associated with the <strong>ProCare</strong><br />

Monitor.<br />

Note: The model of the Monitor determines which symbols<br />

appear on it.<br />

Attention, consult accompanying documents<br />

Silence<br />

Alarms<br />

+ / - Increase / decrease adjustable settings<br />

Menu<br />

Inflate/Stop<br />

Cycle<br />

History<br />

Print<br />

On/Off<br />

Battery Power<br />

External communications port connector<br />

Charging<br />

Defibrillator-proof type BF equipment<br />

External DC power input<br />

Class II equipment according to IEC 60536<br />

11


IPX1<br />

12<br />

Packaging label depicting the<br />

transportation and storage<br />

atmospheric pressure range<br />

of 500 to 1060 hPa.<br />

The DINAMAP ® <strong>ProCare</strong> Monitor is protected against<br />

vertically falling drops of water and conforms with the IEC<br />

529 standard at level of IPX1. Vertically falling drops shall<br />

have no harmful effects to the Monitor.


Getting Started


Getting Started<br />

Unpacking the Monitor and Accessories<br />

Before attempting to use the <strong>ProCare</strong> Monitor, take a few<br />

minutes to become acquainted with the Monitor and its<br />

accessories. Unpack the items carefully. This is also a good<br />

time to check for any damage or accessory shortage. If there<br />

is a problem or shortage, contact GE <strong>Medical</strong> Systems<br />

Information Technologies.<br />

It is recommended that all the packaging be retained, in case<br />

the Monitor must be returned for service in the future.<br />

Setting up BP Connections<br />

1. Connect the end of<br />

the air hose that has<br />

quick-release clips to<br />

the BP connector on<br />

the front of the<br />

Monitor. Make sure<br />

that the hose is not<br />

kinked or<br />

compressed.<br />

Note: To disconnect<br />

the hose from the<br />

Monitor, squeeze the quick-release clips together and pull<br />

the plug from the BP connector.<br />

2. Select appropriate cuff size. Measure patient’s limb and<br />

select appropriately sized cuff according to size marked<br />

on cuff or cuff packaging. When cuff sizes overlap for a<br />

specified circumference, choose the larger size cuff.<br />

Precaution: Accuracy depends on use of proper size cuff.<br />

3. Inspect cuff for damage. Replace cuff when aging, tearing,<br />

or weak closure is apparent. Do not inflate cuff when<br />

unwrapped.<br />

Precaution: Do not use cuff if damaged.<br />

4. Connect the cuff to the air hose. Refer to the BP section<br />

for complete cuff connection instructions.<br />

Warning: It is mandatory that the appropriate hose and<br />

cuff combination be used. Any attempt to modify the<br />

hose will inhibit the Monitor from switching between the<br />

neonatal and adult measurement modes.<br />

15


Note: Care should be taken in reconnecting the cuff to a<br />

hose, ensuring that threads of the cuff and hose are in<br />

alignment and no cross-threading occurs.<br />

5. Refer to the BP section of this manual for complete<br />

instructions on taking an accurate BP determination.<br />

Note: Use only CRITIKON ® Blood Pressure Cuffs. The<br />

size, shape, and bladder characteristics can affect the<br />

performance of the instrument. Inaccurate readings may<br />

occur unless CRITIKON ® Blood Pressure Cuffs are used.<br />

Refer to Appendix E for reorder codes.<br />

Setting up SpO2 Connections<br />

1. Plug the appropriate SpO 2 sensor into the SpO 2 sensor<br />

extension cable.<br />

2. Then plug the SpO 2 sensor extension cable into the SpO 2<br />

sensor connector on the Monitor.<br />

3. Refer to the applicable SpO 2 section of this manual for<br />

complete instructions on monitoring SpO 2 .<br />

Setting up Temperature Connections<br />

1. Connect the<br />

temperature probe<br />

cable to the<br />

temperature probe<br />

connector on the<br />

Monitor.<br />

2. Insert the temperature<br />

probe into the probe<br />

holster at the side of<br />

the Monitor.<br />

16


Getting Started<br />

3. Refer to the TURBOTEMP section of this manual for<br />

complete instructions on taking a temperature reading.<br />

Setting up the Printer (Installing the Paper)<br />

1. With the Monitor<br />

powered on, turn it so<br />

that the side with the<br />

printer is facing you.<br />

2. While grasping the side<br />

of the Monitor, lift the<br />

printer door open by<br />

placing your thumb in<br />

the indented area and<br />

pulling. The printer<br />

door will pop open.<br />

3.Place the roll of paper into the<br />

compartment so that the end of<br />

the paper comes off the right-side<br />

of the roll (paper is wound<br />

around the roll clockwise). Push<br />

the roll all the way to the back of<br />

the printer cavity, making sure the<br />

paper extends out of the printer<br />

cavity at least two inches.<br />

4.Firmly press the door to close it.<br />

5.Refer to the Printer section of<br />

this manual for complete<br />

instructions.<br />

Power Sources<br />

The <strong>ProCare</strong> Monitor is designed to operate from an internal<br />

lead-acid battery (see “Specifications” in Product Overview<br />

section).<br />

Note: The <strong>ProCare</strong> Monitor is not designed to operate<br />

without an internal battery.<br />

Powering the Monitor: Battery and DC Supply<br />

Before the <strong>ProCare</strong> Monitor is used for the first time, the<br />

battery should be charged in the Monitor for at least 8 hours.<br />

With external DC power connected, the green CHARGING<br />

indicator will light to indicate that the battery is charging.<br />

17


When the Monitor is operating on battery power and the<br />

BATTERY LOW alarm is not active, the BATTERY indicator is<br />

backlit green. When the Monitor is operating on battery<br />

power and the BATTERY LOW alarm is active, the BATTERY<br />

indicator flashes green, the LOW indicator flashes amber,<br />

and the medium priority alarm sounds until it is<br />

acknowledged. Press the Silence button to acknowledge this<br />

alarm. Once it is acknowledged, the indicators continue to<br />

flash, but the audible alarm is silenced for 10 minutes. Once<br />

the BATTERY LOW condition becomes active, the Monitor<br />

should be connected to a DC power supply to recharge the<br />

battery (refer to “Power Requirements” in Product Overview<br />

section). If the Monitor continues to be used (approx. 10<br />

min) without charging the battery, the Monitor enters a failsafe<br />

mode: all functions are shutdown except for the alarm<br />

error code in the systolic window, and a constant alarm tone<br />

sounds for up to 10 minutes. After 10 minutes the alarm tone<br />

automatically shuts off and the alarm error code remains in<br />

the systolic window.<br />

Battery charging will take<br />

place as long as the Monitor<br />

remains connected to an<br />

external DC power source.<br />

Notes<br />

• To prolong the life of the<br />

battery, keep the<br />

Monitor connected to a<br />

DC power supply<br />

whenever possible. NEVER allow the battery to become<br />

completely discharged. A fully charged battery will<br />

power the Monitor for approximately 2 hours. To ensure<br />

full charge cycles, replace only with a recommended<br />

battery. If the Monitor is to be stored for some time, first<br />

charge the battery and then remove it and store it<br />

separately from the Monitor.<br />

18


Getting Started<br />

Replacing the Battery<br />

1. Unplug the Monitor from the DC power source.<br />

2. Looking at the bottom of the <strong>ProCare</strong> Monitor, remove<br />

the battery compartment cover by removing the four<br />

screws that secure the cover and help card tray.<br />

3. Remove the help card tray and battery door cover.<br />

3. Remove the old battery and disconnect the wires. Attach<br />

the battery wires to the new battery, ensuring the red<br />

terminal (+) is connected to the red wire and the black<br />

terminal (-) is connected to the black wire.<br />

4. Insert the battery into the compartment.<br />

5. Then replace the cover, help card tray, and screws. Insert<br />

the external DC power converter plug into the external<br />

DC power socket and plug into an AC outlet.<br />

19


General Caution<br />

• Do not touch either the pin of the DC input connector<br />

or the terminals within the battery compartment and<br />

the patient at the same time.<br />

Switching the Monitor On and Off<br />

To switch the <strong>ProCare</strong> Monitor on, push the power On/Off<br />

button.<br />

As the Monitor powers up, it will run a short self-test routine,<br />

which will flash all the indicator lights and then beep the<br />

warning speaker.<br />

To switch the Monitor off, push the power On/Off button<br />

again. This will terminate any measurements that may be in<br />

progress and automatically deflate the cuff. The Monitor also<br />

has an auto turn-off feature, which turns it off after 35<br />

minutes of inactivity.<br />

Setting the Date and Time<br />

To set the date and time on the <strong>ProCare</strong> Monitor, you must<br />

first access the configuration mode. The following list shows<br />

which settings appear in which windows.<br />

Setting: Window Text in Window<br />

• Day: Diastolic<br />

• Month: MAP/Cuff<br />

• Year: Systolic<br />

• Hour: min<br />

• Minute: min<br />

Procedures<br />

1. With the Monitor off, press and hold the Menu button at<br />

the same time as pressing the On/Off button for 3<br />

seconds.<br />

2. The Monitor automatically switches on in configuration<br />

mode.<br />

20


Getting Started<br />

3. To set the date and time, press the Menu button to move<br />

from one setting to another. (You will need to press the<br />

Menu button several times until the year setting appears.)<br />

Use the +/- buttons to increment or decrement the<br />

individual settings. Once you are finished changing a<br />

setting, press the Menu button again to move to the next<br />

setting.<br />

Note: For the date and time to be saved, you must<br />

advance the menu through the min setting.<br />

4. To exit config mode, press the On/Off button.<br />

21


Product Overview


Product Overview<br />

Buttons<br />

1 Silence button: Press to mute audible alarms. Any alarm<br />

active that is acknowledgeable is also removed whenever<br />

this key is pressed. When pressed after alarm sounds<br />

(silence active), the silence icon (bell) lights to indicate<br />

that audible alarms have been silenced for 2 minutes<br />

2 Alarms button: Press to view or adjust parameter alarm<br />

settings<br />

3 +/- button (Plus/Minus): Press the + button to increase an<br />

adjustable setting and the - button to decrease an<br />

adjustable setting. This button is active only when a usersetting<br />

mode (limit or menu) is active<br />

4 Menu button: Press to access menu settings that can be<br />

adjusted while in clinical mode (i.e., ALARM VOLUME,<br />

PULSE VOLUME, INFLATE PRESSURE; refer to Operating<br />

Modes in this section for a description of clinical mode)<br />

5 SpO 2 sensor connector: SpO 2 sensor extension cable<br />

attaches here<br />

6 BP connector: BP cuff hose attaches here<br />

7 Inflate/Stop button: Press to start a manual BP<br />

determination or stop any BP determination<br />

8 Temperature probe holster: Temperature probe is stored<br />

here<br />

9 Cycle button: Press to start Auto Cycle or STAT mode<br />

25


10 Temperature probe cover storage: Box of probe covers is<br />

stored here<br />

11 History button: Press to activate the history mode. When<br />

activated, it displays the most recent entries stored. Press<br />

and hold the button for 2 seconds to clear all entries<br />

stored<br />

12 Print button: Press to print currently displayed values or all<br />

stored entries when in history mode<br />

13 On/Off button: Controls on/off state of monitor; push for<br />

power on and push again for power off<br />

14 Temperature probe connector: Temperature probe cable<br />

attaches here<br />

26


Product Overview<br />

Front Panel<br />

15 Silence icon: when Silence button is pressed after alarm<br />

sounds (silence active), silence icon (bell) lights to indicate<br />

that audible alarms have been silenced for 2 minutes<br />

16 Systolic window: 3-digit red LED indicates measured<br />

systolic BP in mmHg<br />

17 Diastolic window: 3-digit red LED indicates measured<br />

diastolic BP in mmHg<br />

18 Alarm volume indicator: lights to indicate you are making<br />

a change to the alarm volume<br />

19 Pulse volume: lights to indicate you are making a change<br />

to the pulse volume<br />

20 Inflate pressure: lights to indicate you are making a<br />

change to the inflation pressure<br />

21 Pulse Rate window: 3-digit yellow LED shows pulse rate in<br />

beats per minute<br />

22 SpO 2 pulse indicator: Red LED bar flashes to indicate that<br />

real-time pulse rate measurements are being derived from<br />

SpO 2 signals<br />

23 SpO 2 window: 3-digit red LED indicates oxygen saturation<br />

in %<br />

27


24 MAP/Cuff window: 3-digit red LED indicates measured<br />

MAP in mmHg and shows instantaneous cuff pressure<br />

during BP determination<br />

25 Min window: Displays the BP mode if manual or STAT is<br />

the cycle time when in Auto Cycle mode<br />

26 Battery power indicator: Green LED indicates the Monitor<br />

is operating on battery power<br />

27 Low battery power indicator: Yellow LED indicates LOW<br />

charge status of internal battery<br />

28 Charging indicator: Green LED indicates presence of<br />

external power source and battery charging<br />

29 Temperature window: 4-digit red LED indicates measured<br />

temperature<br />

28


Product Overview<br />

Rear Panel<br />

30 Data interface connector: Host communications port<br />

(15 pin D-type RS-232 serial port) for use only with<br />

equipment conforming to IEC 601-1, configured to<br />

comply with IEC 601-1-1<br />

31 Printer compartment<br />

29


Left-Side Panel<br />

32 Printer compartment<br />

Right-Side Panel<br />

33 External DC power socket: To be used with approved GE<br />

<strong>Medical</strong> Systems Information Technologies AC-DC power<br />

converter ONLY<br />

30


Product Overview<br />

Windows<br />

Each derived vital sign has an associated window for<br />

displaying the value. For each window, the vital sign’s name<br />

and unit of measure are labeled above and to the right of it,<br />

respectively. An additional window--the min window--is<br />

available for displaying the BP mode or chosen AUTO<br />

CYCLE selection.<br />

Indicators<br />

Indicators are text messages and icons that are positioned on<br />

the front of the Monitor and can be either backlit red or<br />

green. For each vital sign that has user-adjustable limits, two<br />

indicators (HIGH, LOW) appear to the right of its window.<br />

Operating Modes<br />

The <strong>ProCare</strong> Monitor can operate in one of four modes:<br />

clinical, configuration, advanced configuration, and service.<br />

Clinical mode is the Monitor’s normal operating mode.<br />

While this mode is active, alarm limits and a few other<br />

commonly used settings are adjustable. All parameters are<br />

available for monitoring in this mode.<br />

Configuration and advanced configuration modes display the<br />

software revision and allows you to configure defaults for<br />

some settings that are available in clinical mode, as well as<br />

some less commonly used settings that are only adjustable in<br />

these modes. No parameters are operable in these modes,<br />

therefore, patient monitoring should be suspended.<br />

Entering Configuration Mode<br />

1. With the Monitor off, press and hold the Menu button at<br />

the same time as pressing the On/Off button for 3<br />

seconds.<br />

2. The Monitor automatically switches on in configuration<br />

mode.<br />

Refer to the Service Manual for instructions for use<br />

concerning advanced configuration and service mode.<br />

31


Parameter Modes<br />

The <strong>ProCare</strong> Monitor has three parameter modes: offline,<br />

ready, or operate.<br />

A parameter is in offline mode when its vital sign(s) are not<br />

checked against user-set limits, alarm conditions detected by<br />

the parameter do not generate alarms, and no vital sign(s)<br />

data is displayed.<br />

A parameter is in ready mode when its vital signs are not<br />

checked against user-set limits, alarm conditions detected by<br />

the parameter do not generate alarms, and no vital sign(s)<br />

data is displayed. However, information regarding the<br />

connection of a sensor is communicated in this mode.<br />

A parameter is in operate mode when the appropriate vital<br />

signs are being checked against user-set limits and alarming<br />

conditions detected by the parameter generate alarms. Vital<br />

sign(s) data from the parameter is displayed.<br />

When the Monitor is turned on and no sensor is connected,<br />

the parameter remains in offline mode. Upon detection of a<br />

sensor, the parameter auto-switches to ready mode. Upon<br />

detection of valid patient data, the parameter auto-switches<br />

to operate mode.<br />

User Modes<br />

The <strong>ProCare</strong> Monitor has four user modes that are available<br />

during clinical operating mode: Menu, Cycle, Limit<br />

Adjustment, and History.<br />

The Menu mode allows you to access and change the three<br />

settings associated with the following indicators: ALARM<br />

VOLUME, PULSE VOLUME, AND INFLATE PRESSURE. To<br />

activate this mode, press the Menu button. With each press<br />

of the Menu button, the indicator appears in flashing green<br />

with the associated value appearing in red in the Diastolic<br />

window. As the Menu button is pressed, the indicators<br />

appear in the following order: ALARM VOLUME, PULSE<br />

VOLUME, AND INFLATE PRESSURE. To change the<br />

associated value, simply use the +/- button to increment or<br />

decrement, respectively. After 15 seconds of not pressing the<br />

32


Product Overview<br />

Menu button, the Menu mode is automatically exited.<br />

Otherwise, you can exit the Menu mode by pressing the<br />

Menu button one more time after viewing the oldest entry.<br />

Upon exiting Menu mode, the main monitoring screen is<br />

displayed. Alarm and pulse volume settings are retained after<br />

power-off. INFLATE PRESSURE is reset to its configured<br />

default after power-off.<br />

The Cycle mode allows you to access Auto Cycle and STAT<br />

modes. Refer to the BP section for more information.<br />

The History mode allows you to access the stored patient<br />

data. Refer to the History section for more information.<br />

The Limit Adjustment mode allows you to change alarm<br />

limit settings that are used while monitoring a patient. All<br />

limit alarm settings return to their default settings after<br />

power-off. The range and increment/decrement steps for<br />

each derived vital sign that has adjustable limits are<br />

described in each parameter section. The step size specified<br />

(which cannot be adjusted) tells how much the limit value<br />

will change per increment/decrement key press and also<br />

dictates how close together a pair of limits can be.<br />

Limit-adjustable vital signs are displayed in the following<br />

order: Systolic (HIGH, LOW), Diastolic (HIGH, LOW), Pulse<br />

Rate (HIGH, LOW), and SpO 2 (HIGH, LOW).<br />

Note: The Temperature and MAP (mean arterial pressure)<br />

vital signs are not checked against alarm limits.<br />

Sounds<br />

The Monitor generates sounds based upon user interaction,<br />

parameter events, parameter and system alarms, and low<br />

battery alarms.<br />

User interaction sounds include positive key tone and<br />

negative key tone. The positive key tone sounds one highpitched<br />

tone when you press a button and the Monitor is<br />

able to perform the intended function. The negative key tone<br />

sounds three low-pitched tones when you press a button and<br />

the Monitor is unable to perform the intended function.<br />

33


Parameter-specific sounds are related to the functioning of<br />

each parameter: NIBP, Temperature, and SpO 2 . Refer to the<br />

individual parameter sections for definitions and sounds.<br />

Alarm-specific sounds include medium and high priority. The<br />

medium-priority alarm sounds three high-pitched tones. The<br />

high-priority alarm sounds three high-pitched tones followed<br />

by two high-pitched tones. When alarms of both priorities<br />

are active, only the high-priority alarm sound is audible.<br />

A sound is generated when AC power is lost while patient<br />

monitoring is active.<br />

Power Sources<br />

The <strong>ProCare</strong> Monitor is designed to operate from an internal<br />

lead-acid battery. For replacement rechargeable batteries,<br />

please refer to the Service section of this manual.<br />

34


Product Overview<br />

Specifications<br />

Mechanical<br />

Dimensions Height: 9.7 in (24.7 cm)<br />

Width: 8.6 in (21.9 cm)<br />

without Temperature<br />

10.0 in (25.4 cm) with Temp<br />

Depth: 5.3 in (13.5 cm)<br />

Weight, Including Battery 5.68 lb (2.58 kg)<br />

Mountings Self-supporting on rubber feet<br />

Portability Carried by handle<br />

Classification Information Mode of operation:<br />

continuous<br />

Degree of protection against<br />

harmful ingress of water: Dripproof<br />

IPX1<br />

Power Requirements<br />

Power Converter US: P/N: 2009460-001<br />

Protection against electrical<br />

shock: Class II<br />

AC input: 120 VAC/60 Hz<br />

24W<br />

DC output voltage; 12VDC<br />

at 1A<br />

The AC mains power adapter<br />

contains a nonresettable and<br />

nonreplaceable fuse.<br />

Power Converter UK & EUR: P/N UK: 2008538-001<br />

P/N EUR: 2009539-001<br />

Protection against electrical<br />

shock: Class II<br />

AC input: 230-240 VAC/50 Hz<br />

92mA<br />

DC output voltage; 12VDC<br />

at 1A<br />

35


36<br />

The AC mains power adapter<br />

contains a nonresettable and<br />

nonreplaceable fuse.<br />

Monitor Protection against electrical<br />

shock: Internally powered or<br />

Class II when powered from<br />

specified external power<br />

supply.<br />

DC input voltage: 12 VDC,<br />

supplied from a source<br />

conforming to IEC 601-1.<br />

Fuses: The Monitor contains<br />

four fuses. The fuses are autoresettable<br />

and mounted within<br />

the Monitor. The fuses protect<br />

the low voltage DC input, the<br />

battery, the remote alarm<br />

output, and the +5 V output<br />

on the host port connector.<br />

Battery: 6 volt, 3.3 amp-hours<br />

protected by internal autoresetting<br />

fuse and thermal<br />

protection.<br />

Minimum operation time: 2<br />

hrs (5 min cycle with adult cuff<br />

at 25 °C, SpO 2 active at 60<br />

bpm, Temp in monitor mode,<br />

printout of current values<br />

every 5 min) from full charge.<br />

Time for full recharge: Approx.<br />

5 hrs from full discharge when<br />

the Monitor is switched off and<br />

approx. 8 hrs when the Monitor<br />

is switched on.<br />

Environmental<br />

Operating Temperature + 5 °C to + 40 °C<br />

(+ 41 °F to + 104 °F)<br />

Operating Atmospheric<br />

Pressure 700 hPa to 1060 hPa


Product Overview<br />

Storage Temperature – 20 °C to + 50 °C<br />

(– 4 °F to + 122 °F)<br />

Storage/Transportation<br />

Atmospheric Pressure 500 hPa to 1060 hPa<br />

Humidity Range 5% to 95% noncondensing<br />

Radio Frequency Complies with IEC<br />

Publication 601-1-2 (April<br />

1993) <strong>Medical</strong> Electrical<br />

Equipment, Electromagnetic<br />

Compatibility Requirements<br />

and Tests and CISPR 11<br />

(Group 1, Class B) for radiated<br />

and conducted emissions.<br />

IPX1<br />

The DINAMAP ® <strong>ProCare</strong> Monitor is<br />

protected against vertically falling drops of<br />

water and conforms with the IEC 529<br />

standard at level of IPX1. No harmful<br />

effects will come of vertically falling drops<br />

of water making contact with the Monitor.<br />

37


Printer


41<br />

Printer<br />

Description<br />

The <strong>ProCare</strong> Monitor comes with an optional text-only<br />

printer. Each time a printout is started, the following<br />

information is printed: GE <strong>Medical</strong> Systems header, monitor<br />

name; model number; current software revision; a place for<br />

patient name and hand-written comments; a place for the<br />

column labels, parameter labels, or unit of measure; date;<br />

and vital signs data, if available. On some models, a pencil<br />

icon appears instead of the name and comments labels.<br />

Installing the Paper<br />

Refer to the Getting Started section for instructions.<br />

Print Button<br />

The Print button initiates two types of printouts: currently<br />

displayed values and History.<br />

By pressing the Print button while the main monitoring<br />

screen is viewable, a printout of the currently displayed<br />

values is generated. Since the currently displayed values may<br />

have been derived at different times (e.g., the BP values are 5<br />

minutes old, while Temp was just completed), the Monitor<br />

prints the value along with a time stamp of when that value<br />

was derived. Values are printed in order of the most recent<br />

to the oldest.<br />

By pressing the Print button when in History mode, all<br />

entries currently stored in the history are printed in order of<br />

the most recent to the oldest.<br />

Note: If the Print button was pressed during the first 10<br />

seconds of SpO 2 monitoring, dashes will appear for SpO 2<br />

and pulse rate readings.<br />

The availability of the printer is determined at the time the<br />

printout is started. When the printer is unavailable, the Print<br />

button makes a negative key sound when you press it. The<br />

printer is unavailable if it is out of paper, too hot, or if the<br />

battery is too low, or if the Monitor is in any of the following<br />

modes: Cycle, Alarm limit adjustment, Menu, config, or service.<br />

If no print is visible on the paper, check that the paper roll<br />

has been installed in the correct position (refer to diagram).


To tear off the printout, use a slight sideways action to pull<br />

the paper sharply up across the edge of the door.<br />

Printer Alarms<br />

When any of the alarm conditions occur, the alarm code<br />

flashes in the min window and a high-priority alarm sounds.<br />

When a printer alarm condition is active, you can<br />

acknowledge the alarm by pressing the Silence button.<br />

E10: PRINTER NO PAPER<br />

This alarm is generated when the Print button is pressed and<br />

the printer detects that there is no paper.<br />

E11: PRINTER TOO HOT<br />

This alarm is generated when a printout is in progress and the<br />

printer becomes too hot to print.<br />

E12: BATTERY TOO LOW TO PRINT<br />

This alarm is generated when a printout is in progress and the<br />

battery becomes too low to print.<br />

Storage<br />

Store thermal paper in a cool, dry place. The printed strip<br />

(thermal paper recording) should not be<br />

• exposed to direct sunlight,<br />

• exposed to temperatures over 100 °F/38 °C or relative<br />

humidity over 80%,<br />

• placed in contact with adhesives, adhesive tapes, or<br />

plasticizers such as those found in all PVC page<br />

protectors.<br />

Note: When in doubt about long-term storage conditions,<br />

store a photocopy of the thermal paper recording.<br />

Cautions<br />

• The paper is thermally activated; therefore, do not store<br />

it in a hot place as discoloration may result.<br />

• Use only replacement paper rolls (P/N 770137 for<br />

single rolls, 089100 for box of 10) from GE <strong>Medical</strong><br />

Systems - Accessories and Supplies.<br />

42


Alarms


45<br />

Alarms<br />

The <strong>ProCare</strong> Monitor provides visible and audible indications<br />

of patient-, and system-related alarm conditions. An alarm<br />

can generate an audible indication, visual indication, alarm<br />

message code, and electronic record in the history.<br />

Alarm Codes<br />

All alarm indications are accompanied by an audible signal<br />

unless the Silence button is selected. A microprocessor<br />

system failure will generate a high-pitched audible alarm<br />

regardless of the setting of the Silence button.<br />

There are three categories of alarms: patient-related (limit<br />

and parameter status alarms), system-related (printer, battery,<br />

and memory alarms), and system failures.<br />

Adjusting Alarm Limits<br />

Alarms Button<br />

Pressing the Alarms button activates the limit adjustment<br />

user mode. When the limit adjustment mode is initially<br />

activated, it first displays the systolic high limit value with the<br />

HIGH indicator flashing in red. With each subsequent press<br />

of the Alarms button, the next limit in the sequence is<br />

displayed for adjustment. Press the + button to increase the<br />

displayed limit value and the - button to decrease the<br />

displayed limit value.<br />

To exit limit adjustment mode after setting alarms, you must<br />

progress through all limits until you reach the last one. Then,<br />

after reaching the last limit, immediately press the Alarms<br />

button. The main monitoring screen appears indicating that<br />

you have exited Alarms mode. If monitoring is active, the<br />

current vital signs appear after you have completed your<br />

alarm setting changes. Or, you can let the mode timeout by<br />

not touching the Alarms button until the main monitoring<br />

screen appears indicating that you have exited Alarms mode.<br />

The Monitor returns to all default limit settings after poweroff;<br />

these defaults are adjustable via configuration mode.<br />

Adjustable vital signs limits are displayed in the following<br />

order: Systolic (HIGH, LOW), Diastolic (HIGH, LOW), Pulse<br />

Rate (HIGH, LOW), and SpO 2 (HIGH, LOW). Refer to each<br />

parameter section for ranges.


Note: The Temperature and MAP vital signs are not checked<br />

against alarm limits.<br />

Adjusting the Alarm Volume<br />

You can adjust the alarm volume by pressing the Menu<br />

button. ALARM VOLUME will flash in green with the value in<br />

the Diastolic window. You can set the ALARM VOLUME<br />

range from 1 to 10 (10 being the loudest). Changing the<br />

volume applies to all alarms.<br />

The positive key tone that sounds when you press the +/-<br />

buttons relates directly to the user-set alarm volume. Refer to<br />

User Modes.<br />

Silencing and Acknowledging an Alarm<br />

Silence Button<br />

To silence a patient-related alarm (limit and parameter status<br />

alarms) at anytime, press the Silence button. The silence icon<br />

(a bell) lights to indicate that audible alarms have been<br />

silenced for 2 minutes.<br />

Some patient- and system-related alarms are<br />

acknowledgeable. (Refer to the Alarm Message Codes table<br />

at the back of this section.) For acknowledgeable alarms that<br />

are active when the Silence button is pressed, any associated<br />

audible or visual indication is removed and any associated<br />

alarm message code is no longer displayed.<br />

The silence icon has three states:<br />

• Solid red: silence icon is active.<br />

• Blinking red: alarm silence is not active and at least one<br />

alarm condition is active.<br />

• Off: alarm silence is not active and no alarm condition is<br />

active.<br />

Alarm Sounds<br />

The Monitor produces two different alarm sounds based<br />

upon the priority of the alarm: medium and high priority. The<br />

medium-priority alarm sounds three high-pitched tones. The<br />

high-priority alarm sounds three high-pitched tones followed<br />

46


47<br />

Alarms<br />

by two high-pitched tones. When alarms of both priorities<br />

are active, only the high-priority alarm sound is audible.<br />

Alarm Detection and Priorities<br />

Limit Alarms<br />

The Monitor checks each derived vital sign (except MAP and<br />

Temperature) against user-set limits. A high-limit alarm is<br />

generated when that value is greater than its high limit. A<br />

low-limit alarm is generated when that value is less than its<br />

low limit. All limit alarms are considered high priority.<br />

Parameter Range Default<br />

Systolic High 35 - 290 200<br />

Systolic Low 30 - 285 80<br />

Diastolic High 15 - 220 120<br />

Diastolic Low 10 - 215 30<br />

Pulse Rate High: NELLCOR 35 - 250 150<br />

Pulse Rate Low: NELLCOR 30 - 245 50<br />

Pulse Rate High: MASIMO 35 - 235 150<br />

Pulse Rate Low: MASIMO 30 - 230 50<br />

SpO 2 High 21 - 100 100<br />

SpO 2 Low 20 - 99 90<br />

When a limit violation occurs, the following happens:<br />

• The derived vital sign that is out of limits and the<br />

associated HIGH or LOW indicator flash.<br />

• The high priority alarm sound becomes audible unless<br />

silence is active.<br />

Parameter Status Alarms<br />

The Monitor generates parameter status alarms when<br />

unusual patient or sensor conditions are detected. All


parameter status alarms are considered high priority alarms.<br />

Refer to the Alarm Message Codes table in this section.<br />

When a parameter status alarm occurs, the following<br />

happens:<br />

• Its code flashes in the associated window.<br />

• The high priority alarm sound becomes audible unless<br />

alarm silence is active.<br />

Printer Alarms<br />

Refer to Printer section.<br />

Memory Alarms<br />

Memory alarms occur when battery-backed RAM is<br />

corrupted. When it occurs, all settings are reset to their<br />

factory defaults. When detected, the alarm message code<br />

appears in the Systolic window and the medium-priority<br />

alarm sounds.<br />

Battery Alarms<br />

Refer to “Powering the Monitor” in the Getting Started<br />

section.<br />

System Failure Alarms<br />

System failures are caused by a system software or hardware<br />

failure. When a system failure occurs, the error code is<br />

displayed in the Systolic window, and the Monitor enters a<br />

fail-safe mode in which a constant alarm tone sounds for up<br />

to 10 minutes before the tone is automatically switched off.<br />

Refer to the Alarm Message Codes table in this section.<br />

48


Specifications<br />

Default Settings<br />

Alarm Volume 5<br />

49<br />

Alarms


Alarm<br />

Message<br />

Code<br />

Alarm Detected<br />

50<br />

Acknowledgeable by<br />

pressing Silence?*<br />

E89 BP NO DETERMINATION Yes<br />

E85 BP LEVEL TIMEOUT Yes<br />

E84 BP TOTAL TIMEOUT Yes<br />

E83 BP INFLATION TIMEOUT Yes<br />

E82 EXCESS AIR IN CUFF Yes<br />

E80 BP OVERPRESSURE Yes<br />

E20 SPO2 NO SENSOR Yes<br />

E21 SPO2 REPLACE SENSOR Yes<br />

E22<br />

SPO2 REPOSITION SENSOR<br />

(Masimo ONLY)<br />

Yes<br />

E23 SPO2 SENSOR OFF FINGER Yes<br />

E25 SPO2 NO SIGNAL Yes<br />

E61 TEMP PROBE BROKEN No<br />

E63<br />

TEMP DISCONNECTED OR<br />

WRONG TYPE PROBE<br />

Yes<br />

E66 TEMP PROBE TOO HOT No<br />

E10 PRINTER NO PAPER Yes<br />

E11 PRINTER TOO HOT Yes<br />

E12 BATTERY TOO LOW TO PRINT Yes<br />

E00 MEMORY LOST Yes


Alarm<br />

Message<br />

Code<br />

Alarm Detected<br />

51<br />

Alarms<br />

Acknowledgeable by<br />

pressing Silence?*<br />

930 SYSTEM FAILURE** No<br />

940 SYSTEM FAILURE** No<br />

950 SYSTEM FAILURE** No<br />

951 SYSTEM FAILURE** No<br />

952 SYSTEM FAILURE** No<br />

970 SYSTEM FAILURE** No<br />

971 SYSTEM FAILURE** No<br />

972 SYSTEM FAILURE** No<br />

973 SYSTEM FAILURE** No<br />

974 SYSTEM FAILURE** No<br />

975 SYSTEM FAILURE** No<br />

*Acknowledging an alarm by pressing the Silence button, cancels the alarm.<br />

** Refer to the <strong>ProCare</strong> Service Manual for definitions and instructions.


History


55<br />

History<br />

Description<br />

The History mode allows you to access the stored patient<br />

data. The <strong>ProCare</strong> Monitor can hold up to 25 stored entries<br />

in history. When full, the oldest entry is removed so the most<br />

recent entry can be stored. Additionally, entries are<br />

automatically removed when they become older than 24 hours.<br />

The age of each entry is maintained and displayed in the min<br />

window with a minus sign (-) in front of it when other data<br />

stored for that entry is displayed. For entries that are greater<br />

than 59 minutes old, the age is displayed as HH:MM<br />

(hour:min). For entries that are less than or equal to 59<br />

minutes old, the age is displayed in total minutes.<br />

When viewing entries in History that are out of limits, the<br />

corresponding HIGH or LOW indicator appears in red.<br />

An entry is stored in history at the completion of a BP<br />

determination and at the completion of a successful<br />

predictive temperature measurement. At the end of a BP<br />

determination, systolic, diastolic, MAP, pulse rate, and SpO 2<br />

values are stored. At the end of a temperature determination,<br />

only the temperature value is stored.<br />

Buttons Associated with History<br />

To activate the History mode, press the History button. The<br />

HISTORY indicator flashes green while this mode is active.<br />

With each press of the History button, the patient data<br />

stored with the next oldest entry is displayed. Entries are<br />

displayed from the most recent to the oldest. For example,<br />

the most recent entry could have an age of -0 minutes and<br />

the oldest entry could have an age of -23:59.<br />

After 15 seconds of not pressing the History button, the<br />

History mode is automatically exited. Otherwise, you can<br />

exit the History mode by pressing the History button one<br />

more time after viewing the oldest entry. Upon exiting<br />

History mode, the main monitoring screen is displayed.<br />

Erasing Stored History<br />

To erase stored patient data, press and hold the History<br />

button for a minimum of 2 seconds. All entries that were


stored in history, as well as any patient data displayed on the<br />

Monitor that relates to the previous determination or the<br />

previous temperature measurement is erased.<br />

Windows Associated with History<br />

Each window on the Monitor can be active during History<br />

mode. When the History button is pressed the patient data<br />

stored for each entry is displayed in the applicable windows.<br />

Patient data is displayed from most recent to oldest,<br />

indicated by the age in the min window.<br />

Indicators Associated with History<br />

The History indicator is used to show the state of the history<br />

mode. When History mode is active, the History indicator<br />

flashes green.<br />

56


59<br />

BP<br />

Description<br />

The BP parameter in the <strong>ProCare</strong> Monitor is available with<br />

two types of BP technologies: one calibrated to intra-arterial<br />

pressure and one calibrated to the auscultatory method<br />

(specific technologies are available in select markets). Please<br />

refer to the front of your <strong>ProCare</strong> Monitor to see which BP<br />

technology your monitor contains. The monitors containing<br />

auscultatory technology will have an auscultatory label<br />

above the model number on the front of the Monitor. Then,<br />

refer to the Appendix A: Principles of Noninvasive Blood<br />

Pressure Determination for specific information regarding<br />

both technologies. All user interface options, instructions for<br />

use, and alarms will be the same for both technologies. The<br />

BP parameter is included in all models. Blood pressure is<br />

monitored noninvasively in the <strong>ProCare</strong> Monitor by<br />

oscillometric method.<br />

Note: For neonatal populations, the reference is always the<br />

intra-arterial pressure monitoring method.<br />

The <strong>ProCare</strong> Monitor has three BP modes: 1. Manual, 2. Auto<br />

Cycle, and 3. STAT. The mode is selected by the user. The<br />

actual BP determination is automated and, once it is<br />

complete, the values for systolic pressure, diastolic pressure,<br />

mean arterial pressure, and pulse rate are shown in their<br />

respective windows.<br />

Before each BP determination, the Monitor performs a test<br />

to ensure that the cuff pressure is below a specified level.<br />

The determination is delayed until this condition is met. The<br />

Monitor senses the type of hose being used and<br />

automatically uses adult/pediatric monitoring parameters or<br />

neonatal monitoring parameters, as appropriate.<br />

Audible and visible alarms occur when any of the values for<br />

systolic pressure, diastolic pressure, or pulse rate are outside<br />

their selected high or low limits.<br />

Note: The Monitor will continue to operate until the battery<br />

is completely depleted in order to obtain the full use of the<br />

battery. However, if the battery reaches its “empty” point<br />

during a BP determination, it will simply stop in the middle of<br />

the determination.


Instructions for cleaning and disinfecting BP cuffs are in<br />

Appendix B.<br />

General Warnings<br />

• Connect cuffs and inflation systems only to systems<br />

designed for non-invasive blood pressure monitoring.<br />

Devices with luers and locking luer connectors may be<br />

inadvertently connected to intravascular fluid systems<br />

that may allow air to be pumped into a blood vessel.<br />

•The <strong>ProCare</strong> Monitor will not measure blood pressure<br />

effectively on patients who are experiencing seizures or<br />

tremors.<br />

• Arrhythmias will increase the time required by the<br />

<strong>ProCare</strong> Monitor to determine a blood pressure and<br />

may extend the time beyond the capabilities of the<br />

Monitor.<br />

• In Manual mode, the <strong>ProCare</strong> Monitor displays the<br />

results of the last blood pressure determination for 30<br />

minutes or until another determination is completed. If<br />

a patient’s condition changes between one<br />

determination and the next, the Monitor will not detect<br />

the change or indicate an alarm condition.<br />

• Devices that exert pressure on tissue have been<br />

associated with purpura, skin avulsion, compartmental<br />

syndrome, ischemia and/or neuropathy. To minimize<br />

these potential problems, especially when monitoring<br />

at frequent intervals or over extended periods of time,<br />

make sure the cuff is applied appropriately and<br />

examine the cuff site and the limb distal to the cuff<br />

regularly for signs of impeded blood flow.<br />

• Do not apply external pressure against cuff while<br />

monitoring. Doing so may cause inaccurate blood<br />

pressure values.<br />

• Use care when placing cuff on extremity used to<br />

monitor other patient parameters.<br />

•The <strong>ProCare</strong> Monitor is designed for use only with<br />

CRITIKON ® dual-tube cuffs.<br />

60


61<br />

BP<br />

• Use only accessories approved for use with DINAMAP ®<br />

Monitors. Failure to use recommended accessories may<br />

result in inaccurate readings.<br />

• Blood pressure cuffs should be removed from the<br />

patient when the Monitor is powered off. If the<br />

extremity remains cuffed under these conditions or if<br />

the interval between blood pressure determinations is<br />

prolonged, the patient’s limb should be observed<br />

frequently and the cuff placement site should be<br />

rotated as needed.<br />

General Cautions<br />

• Accuracy of BP measurement depends on using a cuff<br />

of the proper size. It is essential to measure the<br />

circumference of the limb and to select the proper size<br />

cuff. In addition, the air hoses are color-coded<br />

according to patient population. The gray 12- or 24-foot<br />

hose (3.66 m or 7.3 m) is required on patients who<br />

require cuff sizes from infant through thigh cuffs. The<br />

light blue 12-foot hose (3.66 m) is required for the<br />

neonatal cuff sizes #1 through #5.<br />

• If it becomes necessary to move the cuff to another<br />

limb, make sure the appropriate size cuff is used.<br />

• The pulse rate derived from a BP determination may<br />

differ from the heart rate derived from an EKG<br />

waveform because the <strong>ProCare</strong> Monitor measures<br />

actual peripheral pulses, not electrical signals or<br />

contractions from the heart. Differences may occur<br />

because electrical signals at the heart occasionally fail<br />

to produce a peripheral pulse or the patient may have<br />

poor peripheral perfusion. Also, if a patient’s beat-tobeat<br />

pulse amplitude varies significantly (e.g., because<br />

of pulsus alternans, atrial fibrillation, or the use of a<br />

rapid-cycling artificial ventilator), blood pressure and<br />

pulse rate readings can be erratic, and an alternate<br />

measuring method should be used for confirmation.<br />

General Notes<br />

• A patient’s vital signs may vary dramatically during the<br />

use of cardiovascular agents such as those that raise or


lower blood pressure or those that increase or decrease<br />

heart rate.<br />

• Several conditions may cause the BP parameter to<br />

calculate and display only the mean arterial pressure<br />

(MAP) without systolic and diastolic readings. These<br />

conditions include very low systolic and amplitude<br />

fluctuations, so an accurate calculation for these values<br />

can’t be made (e.g., patient in shock); too small of a<br />

difference between systolic and MAP calculations in<br />

relationship to the difference between diastolic and<br />

MAP; or a leak has occurred in the <strong>ProCare</strong> Monitor. If<br />

only the MAP value is displayed, an alarm message<br />

code is displayed in the systolic window, while the<br />

diastolic window remains blank.<br />

• This equipment is suitable for use in the presence of<br />

electrosurgery.<br />

Buttons Associated with BP<br />

The buttons associated with BP are Inflate/Stop and Cycle.<br />

The Inflate/Stop button starts and stops BP determinations.<br />

When a determination is in progress, pressing this button<br />

stops the determination. While in STAT mode, pressing this<br />

button cancels STAT mode, as well a determination if in<br />

progress. When in Auto Cycle mode, pressing this button<br />

starts a determination or cancels a determination if in<br />

progress; it does not change the mode.<br />

Note: While an E80: BP OVERPRESSURE alarm is active, all<br />

presses of this button are ignored.<br />

The Cycle button initiates the Cycle mode, which is where<br />

you can choose STAT or an auto cycle time. Cycle mode<br />

selections appear in the following order: Stat, 1, 2, 3, 4, 5,<br />

10, 15, 20, 30, 60, 90, 120 (minutes), and - - (two dashes).<br />

Choose Stat to start STAT mode. Choose 1-120 to select the<br />

desired cycle time and start Auto Cycle mode. When you<br />

reach the desired setting, do not press the Cycle button<br />

again. After 2 seconds the cycle mode is deactivated.<br />

Choose the two dashes to cancel Auto Cycle mode.<br />

Note: While an E80: BP OVERPRESSURE alarm is active, all<br />

presses of this button are ignored.<br />

62


63<br />

BP<br />

Windows Associated with BP<br />

The windows associated with BP are Systolic, Diastolic,<br />

MAP/Cuff, Pulse Rate, and min. The Systolic, Diastolic,<br />

MAP/Cuff, and Pulse Rate (if SpO 2 is not active) windows<br />

are automatically cleared when a new BP determination is<br />

started. In manual mode, the displayed information is also<br />

cleared when it becomes older than 30 minutes.<br />

The Systolic and Diastolic windows display values after a<br />

determination has completed successfully. While in STAT<br />

mode, the Systolic window flashes the early systolic value if it<br />

is available.<br />

The MAP/Cuff window displays the derived mean arterial<br />

pressure (MAP) following the completion of a successful<br />

determination. During any type of BP determination, the<br />

pressure inside the cuff appears in this window.<br />

The min window displays the BP mode of operation and the<br />

age of the previous BP determination. When both types of<br />

information are present, they flash alternately in this window.<br />

When in Manual mode, two dashes (- -) are displayed. When<br />

in Auto Cycle mode, the chosen Cycle time is displayed (e.g.,<br />

15) When in STAT mode, Stat is displayed. When displayed,<br />

the age of the previous BP determination is preceded by a<br />

minus sign (e.g., - 5).<br />

Indicators Associated with BP<br />

The indicators associated with BP are Systolic HIGH and<br />

LOW, Diastolic HIGH and LOW, AUTO CYCLE and<br />

HISTORY.<br />

The AUTO CYCLE indicator appears solid green when Auto<br />

mode is on. It flashes green when changes are being made to<br />

the current BP mode (e.g., Cycle mode is active). The<br />

HISTORY indicator appears solid green when the age of the<br />

previous BP determination is displayed in the min window.<br />

Parameter Modes<br />

The BP parameter is in operate mode upon power-up. It does<br />

not have a ready mode.


BP Modes of Operation<br />

The <strong>ProCare</strong> Monitor has three BP modes: 1. Manual, 2. Auto<br />

Cycle, and 3. STAT. The mode is selected by the user. BP<br />

determinations are automated and, upon completion, the<br />

values for systolic pressure, diastolic pressure, mean arterial<br />

pressure, and pulse rate are shown in their respective<br />

windows.<br />

Manual BP Determinations<br />

Manual mode allows you to take one blood pressure<br />

determination. Manual mode is always the BP mode of<br />

operation upon power-up. A normal, uninterrupted Manual<br />

determination takes about 40 seconds. Following a<br />

determination, the cuff pressure must drop below 5 mmHg<br />

(neonate) or 15 mmHg (adult) before another determination<br />

can be started.<br />

Manual BP determinations are started by pressing the<br />

Inflate/Stop button. To stop a Manual BP determination<br />

press the Inflate/Stop button. The values displayed in the<br />

Systolic, Diastolic, MAP, and Pulse Rate (if SpO 2 is not<br />

active) windows are cleared after 30 minutes have lapsed.<br />

Auto Cycle Determinations<br />

Auto Cycle mode allows you to take multiple determinations<br />

at user-defined intervals. In the Auto Cycle mode, the<br />

pressure must be below 5 mmHg (neonate) or 15 mmHg<br />

(adult) for at least 30 seconds before the next auto<br />

determination can be started.<br />

Auto Cycle mode is started by selecting the Cycle button.<br />

When in Auto Cycle mode, the AUTO CYCLE indicator<br />

appears solid green. Manual determinations can be taken<br />

while in Auto Cycle mode without affecting when the next<br />

auto determination is to start. You can also change the time<br />

interval while in Auto Cycle mode.<br />

Once the Cycle button is pressed, the first Auto Cycle<br />

determination is started, and the time between<br />

determinations appears in the min window. You can change<br />

the time interval between Auto Cycle determinations by<br />

continuing to press the Cycle button until you reach the<br />

64


65<br />

BP<br />

desired time interval. Time interval selections appear in the<br />

following order: Stat, 1, 2, 3, 4, 5, 10, 15, 20, 30, 60, 90, 120<br />

(minutes), and - - (two dashes). When you reach the desired<br />

time interval, do not press the Cycle button again; after 2<br />

seconds, the chosen time interval is retained and remains in<br />

the min window.<br />

Pressing the Cycle button when in Auto Cycle mode<br />

activates Cycle mode again with two dashes (- -) appearing in<br />

the min window. If you press the Cycle button immediately<br />

after the first press, the next time interval appears in the min<br />

window. If you do not press the Cycle button immediately<br />

after the first press, Cycle mode is deactivated. Press the<br />

Inflate/Stop button to stop the determination in progress<br />

without canceling the Auto Cycle mode. Choose the two<br />

dashes (- -) to cancel Auto Cycle mode.<br />

If the first Auto Cycle determination results in a limit alarm,<br />

another repeat determination is taken to verify the alarm.<br />

This occurs only once.<br />

Whenever an Auto Cycle determination results in a E89: BP<br />

NO DETERMINATION alarm, up to nine more repeat<br />

determinations are attempted in order to achieve valid<br />

values. If at any time during this repeat cycle, the BP NO<br />

DETERMINATION alarm is acknowledged by pressing the<br />

Silence button or the Inflate/Stop button, additional<br />

determinations are not attempted. If the repeat cycle<br />

completes all nine repeat determinations without reaching a<br />

valid value, the Monitor returns to normal Auto Cycle mode.<br />

However, an Auto Cycle mode determination must<br />

complete successfully before a repeat cycle will follow a<br />

future Auto Cycle mode determination that results in an E89:<br />

BP NO DETERMINATION alarm.<br />

STAT BP Determinations<br />

STAT mode allows you to take as many determinations as<br />

possible within a 5-minute time period. The Monitor will<br />

begin another determination once the pressure is below 5<br />

mmHg for 8 seconds (neonates) or 15 mmHg for 4 seconds<br />

(adults), unless the 5-minute period has ended or STAT mode<br />

has been canceled.


Note: BP and BP-derived pulse rate alarm limits are disabled<br />

while in Stat mode.<br />

STAT BP determinations are started by selecting the Cycle<br />

button. Once the Cycle button is pressed, choose Stat. The<br />

Monitor automatically begins a 5-minute period of STAT<br />

determinations.<br />

Note: If the Monitor was previously in Auto mode, the first<br />

STAT BP determination begins after 2 seconds.<br />

After the first STAT determination, an early systolic value<br />

flashes in the associated window. If STAT mode is started<br />

when a determination is already in progress, that<br />

determination becomes the first in the series of STAT<br />

determinations. At the end of STAT mode, the BP mode prior<br />

to entering STAT mode is resumed. To cancel STAT mode,<br />

press the Inflate/Stop button.<br />

User Settings<br />

Mode Settings<br />

There is one mode setting associated with this parameter:<br />

Cycle. The Cycle mode is started by pressing the Cycle<br />

button. While the Cycle mode is active, Cycle selections are<br />

displayed in the min window. Cycle selections appear in the<br />

following order: Stat, 1, 2, 3, 4, 5, 10, 15, 20, 30, 60, 90,<br />

120, - - .<br />

Limit Settings<br />

There are two limit settings associated with this parameter:<br />

HIGH and LOW. Both limit settings are available for Systolic<br />

and Diastolic windows. The range for Systolic HIGH is 35 to<br />

290 mmHg; the range for Systolic LOW is 30 to 285 mmHg.<br />

The range for Diastolic HIGH is 15 to 220 mmHg; the range<br />

for Diastolic LOW is 10 to 215 mmHg. The settings appear in<br />

increments of 5 mmHg.<br />

Neonate Settings<br />

The Monitor determines if a neonate BP cuff is being used<br />

and then checks the systolic limit and adjusts it to an<br />

appropriate limit for neonates.<br />

66


67<br />

BP<br />

Menu Settings<br />

The INFLATE PRESSURE menu setting is associated with the<br />

BP parameter. This option lets you adjust the target pressure<br />

that the Monitor initially pumps to for the next<br />

determination. The settings appear in increments of 5<br />

mmHg. The range available is 100 mmHg to 250 mmHg. If<br />

the Monitor senses a neonate BP cuff in use, it checks the<br />

systolic limit and adjusts it to an appropriate limit for<br />

neonates.<br />

When you change the target pressure, any values from the<br />

previous determinations are cleared from their associated<br />

windows.<br />

Manual determinations use the value chosen for INFLATE<br />

PRESSURE as their target inflation pressure unless a<br />

determination is started within 2 minutes of the completion<br />

of a previous determination. For a determination that is<br />

started within 2 minutes of the previous determination, the<br />

target inflation pressure is adaptive (calculates the target<br />

inflation pressure based on the previous determination). For<br />

all Auto Cycle and STAT determinations (with the exception<br />

of the first determination of the series), the target inflation<br />

pressure is always adaptive.<br />

Sounds Associated with BP<br />

There is one tone associated with this parameter: a single<br />

tone. The tone sounds at the completion of any BP<br />

determination.<br />

Procedures<br />

1. Connect the end of the air hose which has quick-release<br />

clips to the BP connector on the front of the Monitor.<br />

Make sure that the hose is not kinked or compressed.<br />

Note: To disconnect the hose from the Monitor, squeeze<br />

the quick-release clips together and pull the plug from the<br />

BP connector.<br />

2. Select the appropriate blood pressure measurement site.<br />

Because normative values are generally based on this site<br />

and as a matter of convenience, the upper arm is<br />

preferred. When upper arm size or shape, the patient’s


clinical condition, or other factors prohibit use of the<br />

upper arm, the clinician must plan patient care<br />

accordingly, taking into account the patient’s<br />

cardiovascular status and the effect of an alternative site<br />

on blood pressure values, proper cuff size, and comfort.<br />

The figure shows the recommended sites for placing cuffs.<br />

Warning: Do not place the cuff on a limb being used for<br />

intravenous infusion or any area where circulation is<br />

compromised or has the potential to be compromised.<br />

3. If patient is standing, sitting, or inclined, ensure that cuffed<br />

limb is supported to maintain cuff at level of patient’s<br />

heart. If cuff is not at heart level, the difference in systolic<br />

and diastolic values due to hydrostatic effect must be<br />

considered. Add 1.80 mmHg to values for every inch<br />

(2.54 cm) above heart level. Subtract 1.80 mmHg from<br />

values for every inch (2.54 cm) below heart level.<br />

4. Select appropriate cuff size. Measure patient’s limb and<br />

select appropriately sized cuff according to size marked<br />

on cuff or cuff packaging. When cuff sizes overlap for a<br />

specified circumference, choose the larger size cuff.<br />

Precaution: Accuracy depends on use of proper size cuff.<br />

Caution: Do not use an infant cuff with an auscultatory<br />

reference DINAMAP ® <strong>ProCare</strong> Monitor. The neonatal<br />

#5 cuff and neonatal hose may be used on patients with<br />

an arm circumference of 8 - 15 cm.<br />

Note: Use only CRITIKON ® Blood Pressure Cuffs. The<br />

size, shape, and bladder characteristics can affect the<br />

performance of the instrument. Inaccurate readings may<br />

occur unless CRITIKON ® Blood Pressure Cuffs are used.<br />

5. Inspect cuff for damage. Replace cuff when aging, tearing,<br />

or weak closure is apparent. Do not inflate cuff when<br />

unwrapped.<br />

68


69<br />

BP<br />

Precaution: Do not use cuff if structural integrity is<br />

suspect.<br />

6. Connect the cuff to the air hose.<br />

7. Inspect patient’s limb prior to application.<br />

Precaution: Do not apply cuff to areas where skin is not<br />

intact or tissue is injured.<br />

8. Palpate artery and place cuff so that patient’s artery is<br />

aligned with cuff arrow marked “artery.”<br />

9. Squeeze all air from cuff and confirm that the connection<br />

is secure and unoccluded and that tubing is not kinked.<br />

10.Wrap cuff snugly around the patient’s limb. Cuff index<br />

line must fall within the range markings. Ensure that hook<br />

and loop closures are properly engaged so that pressure<br />

is evenly distributed throughout cuff. If upper arm is used,<br />

place cuff as far proximally as possible.<br />

11.Proper cuff wrapping should be snug, but should still<br />

allow space for a finger between patient and cuff. Cuff<br />

should not be so tight as to prevent venous return<br />

between determinations.<br />

Warning: Using a cuff that is too tight will cause venous<br />

congestion and discoloration of the limb, but using a<br />

cuff that is too loose may result in no readings and/or<br />

inaccurate readings.<br />

12.Proceed with monitoring in the Manual, Auto Cycle, or<br />

STAT mode.<br />

Cuff Connections<br />

Quick-Disconnect<br />

Air Hose<br />

Push and twist the male<br />

slip hose connector into<br />

the cuff connector to<br />

ensure a tight fit.


Neonate Air Hose<br />

Push and twist the male<br />

slip hose connector into<br />

the cuff connector to<br />

ensure a tight fit.<br />

Alarms<br />

Alarm Acknowledgeable<br />

by pressing Silence?<br />

BP SYSTOLIC HIGH yes<br />

BP SYSTOLIC LOW yes<br />

BP DIASTOLIC HIGH yes<br />

BP DIASTOLIC LOW yes<br />

E89: BP NO DETERMINATION yes<br />

E85: BP LEVEL TIMEOUT yes<br />

E84: BP TOTAL TIMEOUT yes<br />

E83: BP PUMP TIMEOUT yes<br />

E80: BP OVERPRESSURE yes<br />

E82: EXCESS AIR IN CUFF yes<br />

The alarm codes appear in the Systolic window. When an<br />

alarm is active, it can be acknowledged by starting a new<br />

determination, with the exception of the E80: BP<br />

OVERPRESSURE alarm. BP OVERPRESSURE can only be<br />

acknowledged by pressing the Silence button. During STAT<br />

mode determinations, systolic, diastolic and BP-derived pulse<br />

rate values are not checked against their limits.<br />

Critikon US Patents<br />

4,360,029; 4,501,280; 4,546,775; 4,638,810; 5,052,397;<br />

4,349,034; 4,543,962; 4,627,440; 4,754,761; 5,170,795<br />

European Patents<br />

EP122123, EP205805, EP207807<br />

70


71<br />

BP<br />

Specifications<br />

Cuff Pressure Range 0 to 290 mmHg (adult/ped)<br />

(Normal operating range) 0 to 140 mmHg (neonate)<br />

Blood Pressure Accuracy Meets or exceeds ANSI/AAMI<br />

standard SP-10 (mean error ≤5<br />

mmHg, standard deviation ≤8<br />

mmHg)<br />

Maximum Determination 120 s (adult/ped)<br />

Time 85 s (neonate)<br />

Overpressure Cutoff 300 to 330 mmHg (adult/ped)<br />

150 to 165 mmHg (neonate)<br />

Pulse Rate Range 30 to 200 beats/min (adult/ped)<br />

30 to 220 beats/min (neonate)<br />

Pulse Rate Accuracy ± 3.5%<br />

Factory Default Settings<br />

Systolic Limits (mmHg) HIGH: 200<br />

LOW: 80<br />

Diastolic Limits (mmHg) HIGH: 120<br />

LOW: 30<br />

Inflation Pressure 160 mmHg (adult/ped)<br />

110 mmHg (neonate)<br />

Cycle button 15<br />

All DINAMAP ® Monitor regulatory and accuracy studies<br />

have been performed using CRITIKON ® Blood Pressure<br />

Cuffs. Use only CRITIKON ® Blood Pressure Cuffs. The<br />

size, shape, and bladder characteristics can affect the<br />

performance of the instrument. Inaccurate readings may<br />

occur unless CRITIKON ® Blood Pressure Cuffs are used.


SpO 2


NELLCOR* OxiMAX SpO2<br />

NELLCOR ® SpO 2<br />

Description<br />

The SpO 2 parameter in the <strong>ProCare</strong> Monitor is available in<br />

two different leading technologies: NELLCOR ® and<br />

MASIMO SET ® . Please refer to the front of your Monitor to<br />

see which SpO 2 technology your monitor contains. The<br />

SpO 2 technology logo will be on the front fascia of the<br />

Monitor. This section refers to NELLCOR ® SpO 2 technology.<br />

The SpO 2 parameter is included in Models 300 and 400. To<br />

begin SpO 2monitoring, plug the sensor into the NELLCOR ®<br />

DOC-10 sensor extension cable, then plug the cable into the<br />

Monitor. Simply place the SpO 2 sensor on the patient’s<br />

finger; monitoring begins automatically. Functional oxygen<br />

saturation (SpO 2) of arterial blood is noninvasively and<br />

continuously monitored in the <strong>ProCare</strong> Monitor using pulse<br />

oximetry technology from NELLCOR ® . Functional SpO 2 is<br />

the ratio of oxygenated hemoglobin to hemoglobin that is<br />

capable of transporting oxygen. This ratio, expressed as a<br />

percentage, is shown in the SpO 2 window, which is<br />

continually updated.<br />

Pulse rate derived from SpO 2 appears in the Pulse Rate<br />

window. A tone sounds at a rate corresponding to the pulse<br />

rate and at a pitch corresponding to the SpO 2 saturation<br />

level. The pitch is highest at 100% oxygen saturation, and it<br />

continuously decreases as the saturation level falls. The<br />

Monitor displays a pulse amplitude bar. The pulse amplitude<br />

bar graph is proportional to the arterial blood flow.<br />

Audible and visible alarms occur when SpO 2 levels are<br />

outside the alarm limits. When a parameter status alarm<br />

occurs, an alarm message code appears in the SpO 2<br />

window.<br />

Note: Limit alarms, printing, and trending are not available<br />

for the first 10 seconds of SpO 2 monitoring.<br />

*NELLCOR ® is a trademark of Nellcor Puritan Bennett<br />

75


General Warnings<br />

• Do not place SpO2 sensor on patient during magnetic<br />

resonance imaging (MRI). Adverse reactions include<br />

potential burns to patients as a result of contact with<br />

attachments heated by the MRI radio frequency pulse,<br />

potential degradation of the magnetic resonance<br />

image, and potential reduced accuracy of SpO2 measurements. Always remove oximetry devices and<br />

attachments from the MRI environment before<br />

scanning a patient.<br />

• The use of cardio-green and other intravascular dyes at<br />

certain concentrations may affect the accuracy of the<br />

SpO2 measurement.<br />

•The SpO2 function is calibrated to read functional<br />

arterial oxygen saturation. Significant levels of<br />

dysfunctional hemoglobins such as carboxyhemoglobin<br />

or methemoglobin may affect the accuracy of the SpO2 measurement.<br />

• Pulse oximetry readings and pulse signals can be<br />

affected by certain environmental conditions, sensor<br />

application errors, and certain patient conditions. See<br />

the appropriate sections of this manual for specific<br />

safety information.<br />

• The use of accessories, transducers, and cables other<br />

than those specified may result in increased emission<br />

and/or decreased immunity and inaccurate readings of<br />

the Monitor.<br />

General Cautions<br />

• As with any clip-on sensor, pressure is exerted. The<br />

clinician should be cautious in using a clip-on sensor on<br />

patients with compromised circulation (e.g., because of<br />

peripheral vascular disease or vasoconstricting<br />

medications).<br />

• Do not perform any testing or maintenance on a sensor<br />

while it is being used to monitor a patient.<br />

• Bright light sources (e.g., infrared heat lamps, bilirubin<br />

lights, direct sunlight, operating room lights) may<br />

interfere with the performance of the SpO2 function.<br />

76


NELLCOR ® SpO 2<br />

To prevent such interference, cover the sensor with<br />

opaque material.<br />

General Notes<br />

• A patient’s vital signs may vary dramatically during the<br />

use of cardiovascular agents such as those that raise or<br />

lower blood pressure or those that increase or decrease<br />

pulse rate.<br />

•The <strong>ProCare</strong> Monitor that is labeled with NELLCOR ®<br />

Technology is compatible only with NELLCOR ® OxiMAX<br />

sensors and NELLCOR ® DOC-10 sensor extension cable.<br />

• Software development, software validation, and Risk and<br />

Hazard Analysis has been performed to a registered<br />

quality system.<br />

• User or patient-applied parts are latex-free.<br />

Configuration Settings Associated with SpO 2<br />

There are two configuration settings associated with this<br />

parameter: Response Mode (n0d) and SatSeconds (SAt).<br />

Response Mode (n0d) allows the user to specify the<br />

averaging technique to optimize measurements in the<br />

presence of various patient movement. Choose Mode 1<br />

(Normal Response) when patients are active as in exercise<br />

protocols. Choose Mode 2 (Fast Response; default setting)<br />

for the general patient population. The configuration of this<br />

setting affects whether the pulse rate derived from SpO 2 is<br />

displayed in the Pulse Rate window while SpO 2 is in operate<br />

mode. If Mode 1 is chosen, the pulse rate is not displayed. If<br />

Mode 2 is chosen, the pulse rate is displayed.<br />

With traditional alarm management, upper and lower alarm<br />

limits are set for monitoring SpO 2 . During monitoring, as<br />

soon as an alarm limit is violated by as little as one<br />

percentage point, an audible alarm immediately sounds.<br />

When the % SpO 2 fluctuates near an alarm limit, the alarm<br />

sounds each time the limit is violated. To prevent these<br />

nuisance alarms, the <strong>ProCare</strong> Monitor uses the SatSeconds<br />

technique. The SatSeconds technique (SAt) limit-controls<br />

the time that the % SpO 2 level may fall outside the alarm<br />

77


efore an audible alarm sounds. Choose either 0, 10, 25, 50,<br />

or 100 seconds. If 0 is chosen this limit hold-off feature is<br />

disabled.<br />

The SatSeconds “Safety Net” is for patients with saturation<br />

levels having frequent excursions below the limit, but not<br />

staying below the limit long enough for the SatSeconds<br />

time setting to be reached. When 3 or more limit violations<br />

occur within 60 seconds, an alarm sounds even if the<br />

SatSeconds time setting has not been reached.<br />

Buttons Associated with SpO 2<br />

There are no buttons associated with this parameter.<br />

Windows Associated with SpO 2<br />

There is one window associated with this parameter: SpO 2 .<br />

While in offline mode, nothing is displayed in the SpO 2<br />

window. When in ready mode and the parameter senses that<br />

a sensor is connected, a single dash (-) appears in this<br />

window. When it is in operate mode and the parameter is<br />

reporting a valid data, the derived SpO 2 value appears in this<br />

window. The values are displayed in %.<br />

Note: If SpO 2 is the source for Pulse Rate, the Pulse Rate<br />

window is associated with this parameter.<br />

Indicators Associated with SpO 2<br />

There is one indicator associated with this parameter: the<br />

pulse amplitude indicator bar. The red LED bar flashes to<br />

indicate that pulse rate measurements are being derived<br />

from SpO 2 signals and the height of the bar is proportional to<br />

the arterial blood flow.<br />

Parameter Modes<br />

The SpO 2 parameter is in offline mode upon power-up. The<br />

parameter automatically switches from offline to ready mode<br />

when a sensor is connected to the Monitor. The parameter<br />

automatically switches from ready to operate mode when<br />

pulses are detected.<br />

If an SpO 2 SENSOR OFF FINGER or SPO 2 LOST PULSE<br />

alarm is acknowledged, the parameter automatically<br />

switches from operate to ready mode. If a SpO 2 SENSOR<br />

78


NELLCOR ® SpO 2<br />

DISCONNECTED alarm is acknowledged, the parameter<br />

automatically switches from operate to offline mode.<br />

Note: Once either of these alarms have been acknowledged,<br />

SpO 2 monitoring is not resumed until a valid pulse is<br />

detected again.<br />

User Settings<br />

Limit settings<br />

There are two limit settings associated with this parameter:<br />

HIGH and LOW. The range for HIGH is 21 to 100%. The<br />

range for LOW is 20 to 99%. The settings appear in<br />

increments of 1%.<br />

Menu Settings<br />

The PULSE VOLUME menu setting is associated with the<br />

SpO 2 parameter. This option lets you adjust the volume of<br />

the tone that sounds after each detected heartbeat. It can be<br />

adjusted from 0 - 10 (10 being the loudest). If you set the<br />

volume to zero, no tone will sound.<br />

Sounds Associated with SpO 2<br />

An audible tone is provided by the Monitor for each pulse<br />

detected by the NELLCOR ® SpO 2 parameter. The pitch of<br />

the audible tone is directly related to the calculated<br />

saturation value. As the saturation value increases, the pitch<br />

frequency increases continuously with each 1% increase in<br />

SpO 2 . As the saturation value decreases, the pitch frequency<br />

continuously decreases. This audible tone is silenced while<br />

an alarm sounds or the PULSE VOLUME is set to 0. Refer to<br />

“Menu Settings” in this section.<br />

Procedures<br />

1. Select a sensor that is appropriate for the patient and the<br />

clinical situation.<br />

• Use only NELLCOR ® sensors PURPLE and WHITE and<br />

NELLCOR ® DOC-10 pulse oximetery cables. Use of<br />

another pulse oximetry cable will have an adverse effect<br />

on performance. Do not attach any cable that is<br />

intended for computer use to the sensor port. Do not<br />

connect any device other than NELLCOR ® -approved<br />

sensor to the sensor connector.<br />

79


Warning: Do not use a damaged sensor or one with<br />

exposed electrical contacts. Do not use sensor, cables,<br />

or connectors that appear damaged.<br />

Note: Use only NELLCOR ® OxiMAX compatible sensors,<br />

which are available from GE <strong>Medical</strong> Systems -<br />

Accessories and Supplies.<br />

2. Following the directions for use supplied with the sensor,<br />

apply the sensor to the patient.<br />

Warnings<br />

Patient safety:<br />

• If the sensor is are not applied properly, the patient’s<br />

skin could be injured or the ability of the <strong>ProCare</strong><br />

Monitor to measure oxygen saturation could be<br />

compromised. For example, a clip-on sensor should<br />

never be taped shut. Taping the sensor could damage<br />

the patient’s skin or impair the venous return, thus<br />

causing venous pulsation and inaccurate measurement<br />

of oxygen saturation.<br />

• Excessive pressure from the sensor may cause necrosis<br />

of the skin.<br />

• For additional warnings and information, refer to the<br />

NELLCOR ® sensor’s directions for use.<br />

Monitor performance:<br />

•When an SpO2 sensor is on a limb that has a blood<br />

pressure cuff, the SpO2 data will not be valid when the<br />

cuff is inflated. If SpO2 readings are required during<br />

the entire blood pressure determination, attach the<br />

SpO2 sensor to the limb opposite the one with the<br />

blood pressure cuff.<br />

• Remove nail polish and artificial nails. Placing a sensor<br />

on a polished or an artificial nail may affect accuracy.<br />

Cautions<br />

Patient safety:<br />

• Do not place any clip-on sensor in a patient’s mouth or<br />

on a patient’s nose or toe.<br />

• Do not place a clip-on finger sensor on a patient’s<br />

thumb or across a child’s foot or hand.<br />

• The sensor disconnect error message and associated<br />

alarm indicate that the sensor is either disconnected or<br />

80


NELLCOR ® SpO2 the wiring is faulty. The user should check the sensor<br />

connection and, if necessary, replace the sensor, DOC-<br />

10 cable, or both.<br />

• Observe the sensor site frequently to assure adequate<br />

distal circulation. Sensor sites should be checked at<br />

least every 2 hours and rotated at least every 4<br />

hours.<br />

Monitor performance:<br />

• Placing a sensor distal to an arterial line may interfere<br />

with adequate arterial pulsation and compromise the<br />

measurement of SpO2 .<br />

• Place the sensor so that the LEDs and the photodiode<br />

are opposite each other.<br />

3. Plug the SpO2 sensor into the SpO2 sensor extension<br />

cable. Then plug the SpO2 sensor extension cable into the<br />

SpO2 sensor connector.<br />

4. Proceed with monitoring. SpO2 determinations run<br />

continuously and can run simultaneously with other<br />

measurements.<br />

Alarms<br />

Alarm Acknowledgeable<br />

by pressing Silence?<br />

SPO2 HIGH no<br />

SPO2 LOW no<br />

E20: SPO2 SENSOR DISCONNECTED yes<br />

E21: SPO2 REPLACE SENSOR yes<br />

E23: SPO2 SENSOR OFF FINGER yes<br />

E25: SPO2 LOST PULSE no<br />

81


Troubleshooting<br />

This section discusses potential difficulties and suggestions<br />

for resolving them. If the difficulty persists, contact a qualified<br />

service person or your local representative. The service<br />

manual, which is for use by qualified service personnel<br />

provides additional troubleshooting information.<br />

PROBLEM: The pulse amplitude bar indicates a pulse, but no<br />

oxygen saturation or pulse rate values appear on the screen.<br />

CAUSE:<br />

• Excessive patient motion may be making it impossible<br />

for the SpO2 function to find a pulse pattern.<br />

• The sensor may be damaged.<br />

• The patient’s perfusion may be too low to allow the<br />

SpO2 function to measure saturation and pulse rate.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

SpO2 sensor is applied securely and properly, and<br />

replace it if necessary; move the sensor to a new site; or<br />

use a disposable adhesive sensor that may tolerate more<br />

motion.<br />

• Replace the sensor.<br />

PROBLEM: The SpO2 value or the pulse rate changes<br />

rapidly; the pulse amplitude bar is erratic.<br />

CAUSE:<br />

• Excessive patient motion may be making it impossible<br />

for the SpO2 function to find a pulse pattern.<br />

• An electrosurgical unit (ESU) may be interfering with<br />

performance.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

sensor is applied securely and properly, and replace it if<br />

necessary; move the sensor to a new site; use a sensor<br />

that tolerates more motion.<br />

If an ESU is interfering:<br />

• Move the SpO2 cable as far from the ESU as possible.<br />

82


NELLCOR ® SpO 2<br />

• Plug the Monitor and the ESU into different AC circuits.<br />

• Move the ESU ground pad as close to the surgical site as<br />

possible.<br />

• The sensor may need to be replaced with a new sensor.<br />

• If the patient weighs less than 3 kg or more than 40 kg,<br />

apply an OXIMAX, reusable sensors (except DS-100,<br />

OXI-A/N, OXI-P/I), or OxiCliq oxygen transducer to an<br />

appropriate site. These sensors have Faraday shields<br />

which provide added protection from high electronic<br />

noise and ambient light.<br />

PROBLEM: The oxygen saturation measurement does not<br />

correlate with the value calculated from a blood gas<br />

determination.<br />

CAUSE:<br />

•The SpO2 calculation may not have correctly adjusted<br />

for the effects of pH; temperature; CO2 ; fetal<br />

hemoglobin; or 2,3-DPG.<br />

• Accuracy can be affected by incorrect sensor application<br />

or use; intravascular dyes; bright light; excessive patient<br />

movement; venous pulsations; electrosurgical<br />

interference; and placement of a sensor on an extremity<br />

that has a blood pressure cuff, arterial catheter, or<br />

intravascular line.<br />

SOLUTION:<br />

• Check that calculations have been corrected<br />

appropriately for the relevant variable. In general,<br />

calculated saturation values are not as reliable as direct<br />

laboratory hemoximeter measurements.<br />

• If there is excessive light, cover the sensor with opaque<br />

material.<br />

• Circulation distal to the sensor site should be checked<br />

routinely. Refer to the directions for use supplied with the<br />

sensor for requirements on moving the sensor to another<br />

site to ensure adhesion, skin integrity, and correct optical<br />

alignment. If skin integrity changes, move the sensor to<br />

another site.<br />

• Try to keep the patient still, or change the sensor site to<br />

one with less motion.<br />

83


• Observe all instructions, warnings, and cautions in this<br />

manual and in the directions for use of the sensor.<br />

PROBLEM: A valid SpO2 signal was present but has<br />

disappeared.<br />

CAUSE:<br />

• A BP determination on the same limb is in progress.<br />

SOLUTION:<br />

Check the patient.<br />

• An alarm message code appears on the screen, and the<br />

audible alarm will sound immediately.<br />

• Move the sensor to the arm that is not connected to a<br />

blood pressure cuff.<br />

PROBLEM: A REPLACE SENSOR error code has been<br />

detected.<br />

CAUSE:<br />

• The sensor or cable may be the wrong type or defective,<br />

the cabling may be improperly connected.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

proper sensor/cable is applied securely and properly,<br />

and replace it if necessary.<br />

• Disconnect and reconnect the sensor.<br />

PROBLEM: A SENSOR DISCONNECTED error code has<br />

been detected, but the sensor is still connected.<br />

CAUSE:<br />

• The sensor is not completely connected. The sensor<br />

extension cable or sensor wiring is faulty.<br />

SOLUTION:<br />

Check the patient.<br />

• Check the sensor connection to the sensor extension<br />

cable and the sensor extension cable connection to the<br />

monitor. Then, if needed, replace the sensor or the<br />

sensor extension cable.<br />

84


NELLCOR ® SpO 2<br />

Specifications<br />

Measurement Range<br />

SpO2 1 to 100%<br />

Pulse Rate 20 to 250 beats/min<br />

Accuracy and Motion Tolerance<br />

Saturation<br />

Without Motion - Adults* 70 to 100% ±2 digits<br />

Without Motion - Neonate* 70 to 100% ±3 digits<br />

With Motion - Adults/Neo** 70 to 100% ±3 digits<br />

Low Perfusion 70 to 100% ±2 digits<br />

0 to 69% unspecified<br />

Pulse Rate<br />

Without Motion 20 to 250 beats/min ±3 digits<br />

With Motion normal physiologic range<br />

55 to 125 beats/min ±5 digits<br />

Low Perfusion 20 to 250 beats/min ±3 digits<br />

*Adult specifications are shown for OXIMAX MAX-A and MAX-N sensors.<br />

Neonate specifications are shown for OXIMAX MAX-N. Saturation accuracy<br />

will vary by sensor type.<br />

**Applicability: OXIMAX MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.<br />

NELLCOR ® Sensor Accuracy<br />

Note: All NELLCOR ® sensors must be used with the<br />

NELLCOR ® DOC-10 cable; the SCP-10 cable is not<br />

compatible with the <strong>ProCare</strong> Monitor.<br />

Sensor Model SpO 2 Range<br />

70% - 100%<br />

OxiMAX<br />

MAX-A*, MAX-AL* ±2 digits<br />

MAX-N* † (Adult) ±2 digits<br />

MAX-N* † (Neonate) ±3 digits<br />

MAX-P* ±2 digits<br />

MAX-I* ±2 digits<br />

MAX-R* ‡<br />

±3.5 digits<br />

OxiCliq ®<br />

OxiCliq A ±2.5 digits<br />

OxiCliq P ±2.5 digits<br />

85


OxiCliq N † (Adult) ±2.5 digits<br />

OxiCliq N † (Neonate) ±3.5 digits<br />

OxiCliq I ±2.5 digits<br />

Reusable Sensor Models<br />

D-YS (Infant to Adult) ±3 digits<br />

D-YS (Neonate) ±4 digits<br />

D-YS with D-YSE ±3.5 digits<br />

D-YS with D-YSPD ±3.5 digits<br />

DS-100A ±3 digits<br />

OXI-A/N (Adult) ±3 digits<br />

OXI-A/N (Neonate) ±4 digits<br />

OXI-P/I ±3 digits<br />

* The accuracy specification under motion conditions is ±3. For a definition<br />

of motion, contact NELLCOR ® Technical Services or your local<br />

representative.<br />

†<br />

The MAX-N and the OxiCliq N were tested on patients >40 kg.<br />

‡<br />

The accuracy specification has been determined between saturations of<br />

80%-100%.<br />

Neonatal Sensor Accuracy<br />

When sensors are used on neonatal subjects as<br />

recommended, the specified accuracy range is increased by<br />

±1 digit, to account for the theoretical effect on oximeter<br />

measurements of fetal hemoglobin in neonatal blood. For<br />

example, MAX-N accuracy on neonates is ±3 digits, rather<br />

than ±2 digits.<br />

Sensor Light Source<br />

Wavelength Infrared: 890 nm (nominal)<br />

Red: 660 nm (nominal)<br />

Power Dissipation Infrared: 22.5 mW (max)<br />

Red: 30 mW (max)<br />

Factory Default Settings<br />

SpO 2 (%) HIGH Alarm Limit: 100<br />

SpO 2 (%) LOW Alarm Limit: 90<br />

Response Mode 2 (for Mode 2: Fast Response)<br />

SatSeconds 0<br />

86


NELLCOR ® SpO 2<br />

NELLCOR ® Patents<br />

US Patent No. 4,621,643; 4,653,498; 4,700,708; 4,770,179;<br />

4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136;<br />

5,351,685; 5,421,329; 5,485,847; 5,533,507; 5,577,500;<br />

5,803,910; 5,853,364; 5,865,736; 6,083,172; Re. 35,122 and<br />

foreign equivalents.<br />

87


MASIMO SET® SpO 2<br />

Masimo Set* SpO 2<br />

Description<br />

The SpO 2 parameter in the <strong>ProCare</strong> Monitor is available in<br />

two different leading technologies: NELLCOR ® and<br />

MASIMO SET ® . Please refer to the front of your <strong>ProCare</strong><br />

Monitor to see which SpO 2 technology your monitor<br />

contains. The SpO 2 technology logo will be on the front<br />

fascia. This section refers to MASIMO SET ® SpO 2<br />

technology.<br />

The SpO 2 parameter is included in Models 300 and 400.<br />

Functional oxygen saturation (SpO 2) of arterial blood is<br />

noninvasively and continuously monitored in the <strong>ProCare</strong><br />

Monitor using pulse oximetry technology from MASIMO<br />

SET ® . Functional SpO 2 is the ratio of oxygenated hemoglobin<br />

to hemoglobin that is capable of transporting oxygen. This<br />

ratio, expressed as a percentage, is shown in the SpO 2<br />

window, which is continually updated.<br />

Pulse rate when associated with SpO 2 appears in the Pulse<br />

Rate window. A tone sounds at a rate corresponding to the<br />

pulse rate and at a pitch corresponding to the SpO 2<br />

saturation level. The pitch is highest at 100% oxygen<br />

saturation, and it becomes lower as the saturation level falls.<br />

The Monitor displays a pulse amplitude bar. The pulse<br />

amplitude bar graph is proportional to the arterial blood<br />

flow.<br />

Audible and visible alarms occur when SpO2 levels are<br />

outside the alarm limits. When a parameter status alarm<br />

message code occurs, an alarm message appears in the<br />

SpO2 window.<br />

Note: Limit alarms, printing, and trending are not available<br />

for the first 10 seconds of SpO2 monitoring.<br />

*MASIMO SET ® is a trademark of Masimo Corporation. Possession or<br />

purchase of this device does not convey any express or implied license to<br />

use the device with replacement parts which would, alone, or in<br />

combination with this device, fall within the scope of one or more of the<br />

patents relating to the device.<br />

89<br />

®


General Cautions<br />

• If any measurement does not seem reasonable, first<br />

check the patient’s vital signs by alternate means and<br />

the check the pulse oximeter for proper functioning.<br />

• Inaccurate measurements may be caused by:<br />

- Incorrect sensor application or use<br />

- Significant levels of dysfunctional hemoglobins<br />

(e.g., carboxyhemoglobin or methemoglobin)<br />

- Intravascular dyes such as indocyanine green or<br />

methylene blue<br />

- Exposure to excessive illumination, such as surgical<br />

lamps (especially ones with xenon light source),<br />

bilirubin lamps, fluorescent lights, infrared heating<br />

lamps, or direct sunlight (exposure to excessive<br />

illumination can be corrected by covering the<br />

sensor with a dark or opaque material)<br />

- excessive patient movement<br />

- venous pulsations<br />

- placement of sensor on an extremity with a blood<br />

pressure cuff, arterial catheter, or intravascular line<br />

• The pulse oximeter can be used during defibrillation,<br />

but the readings may be inaccurate for a short time.<br />

• loss of pulse signal can occur in any of the following<br />

situation:<br />

- the sensor is too tight<br />

- there is excessive illumination from light sources<br />

such as surgical lamp, a bilirubin lamp, or sunlight<br />

- a blood pressure cuff is inflated on the same<br />

extremity as the one with a SP02 sensor attached<br />

- the patient has hypotension, severe<br />

vasoconstriction, severe anemia, or hypothermia<br />

- there is arterial occlusion proximal to the sensor<br />

- the patient is in cardiac arrest or is in shock<br />

90


MASIMO SET® SpO 2<br />

Sensors<br />

• Before use, carefully read the Masimo ® sensor<br />

directions for use.<br />

• Use only Masimo ® oximetry sensors for SP02 measurements. Other oxygen transducers (sensors)<br />

may cause improper SpO2 performance.<br />

• Tissue damage can be caused by incorrect application<br />

or use of an Masimo ® sensor, for example by wrapping<br />

the sensor too tightly. Inspect the sensor site as<br />

directed in the sensor Directions for Use to ensure skin<br />

integrity and correct positioning and adhesion of the<br />

sensor.<br />

• Do not use damaged Masimo ® sensors. Do not use a<br />

Masimo ® sensor with exposed optical components. Do<br />

not immerse the sensor in water, solvents, or cleaning<br />

solutions (the sensors and connectors are not<br />

waterproof). Do not sterilize by irradiation, steam, or<br />

ethylene oxide. See the cleaning instructions in the<br />

directions for use for reusable Masimo ® sensors.<br />

• Do not use damaged patient cables. Do not immerse<br />

the patient cables in water, solvents, or cleaning<br />

solutions (the patient cable connectors are not<br />

waterproof). Do not sterilize by irradiation, steam, or<br />

ethylene oxide. See the cleaning instructions in the<br />

directions for use for reusable Masimo ® patient cables.<br />

• Do not use the SpO2 function during magnetic<br />

resonance imaging (MRI). Adverse reactions include<br />

potential burns to patients as a result of contact with<br />

attachments heated by the MRI radio frequency pulse,<br />

potential degradation of the magnetic resonance<br />

image, and potential reduced accuracy of SpO2 measurements. Always remove oximetry devices and<br />

attachments from the MRI environment before<br />

scanning a patient.<br />

• The use of cardio-green and other intravascular dyes at<br />

certain concentrations may affect the accuracy of the<br />

SpO2 measurement.<br />

•The SpO2 function is calibrated to read functional<br />

arterial oxygen saturation. Significant levels of<br />

dysfunctional hemoglobins such as carboxyhemoglobin<br />

91


or methemoglobin may affect the accuracy of the SpO2 measurement.<br />

• The use of accessories, transducers, and cables other<br />

than those specified may result in increased emission<br />

and/or decreased immunity and inaccurate readings of<br />

the Monitor.<br />

• As with any clip-on sensor, pressure is exerted. The<br />

clinician should be cautious in using a clip-on sensor on<br />

patients with compromised circulation (e.g., because of<br />

peripheral vascular disease or vasoconstricting<br />

medications).<br />

• Do not perform any testing or maintenance on a sensor<br />

while it is being used to monitor a patient.<br />

• Bright light sources (e.g., infrared heat lamps, bilirubin<br />

lights, direct sunlight, operating room lights) may<br />

interfere with the performance of the SpO2 function.<br />

To prevent such interference, cover the sensor with<br />

opaque material.<br />

General Notes<br />

• A patient’s vital signs may vary dramatically during the<br />

use of cardiovascular agents such as those that raise or<br />

lower blood pressure or those that increase or decrease<br />

pulse rate.<br />

•The <strong>ProCare</strong> Monitor that is labeled with MASIMO SET ®<br />

Technology is compatible only with MASIMO SET ®<br />

sensors.<br />

• Software development, software validation, and Risk and<br />

Hazard Analysis has been performed to a registered<br />

quality system.<br />

• User or patient-applied parts are latex-free.<br />

Configuration Settings Associated with SpO 2<br />

There are three configuration settings associated with this<br />

parameter: Averaging Time (n0d), FastSAT (Sat), and<br />

Sensitivity Mode (Sen).<br />

92


MASIMO SET® SpO 2<br />

Averaging Time (n0d) allows you to choose the number of<br />

seconds over which SpO 2 data is averaged. Choose 4 to 16<br />

in steps of 2.<br />

FastSAT (Sat) allows you to choose 0 (for Off) or 1 (for On).<br />

If FastSAT is configured to 1 (On), the SpO 2 values are<br />

calculated quicker.<br />

Sensitivity Mode (Sen) setting allows you to adjust the<br />

thresholds for calculating SpO 2 values under low perfusion<br />

conditions. Choose 1 (low perfusion-Maximized) or 2 (low<br />

perfusion-Default).<br />

Buttons Associated with SpO 2<br />

There are no buttons associated with this parameter.<br />

Windows Associated with SpO 2<br />

There is one window associated with this parameter: SpO 2 .<br />

While in offline mode, nothing is displayed in the SpO 2<br />

window. When in ready mode and the parameter senses that<br />

a sensor is connected, a single dash (-) appears in this<br />

window. When it is in operate mode and the parameter is<br />

reporting valid data, the derived SpO 2 value appears in this<br />

window. The values are displayed in %.<br />

Note: If SpO 2 is the source for Pulse Rate, the Pulse Rate<br />

window is associated with this parameter.<br />

Indicators Associated with SpO 2<br />

There is one indicator associated with this parameter: the<br />

pulse amplitude indicator bar. The red LED bar flashes to<br />

indicate that pulse rate measurements are being derived<br />

from SpO 2 signals and the height of the bar is proportional to<br />

the arterial blood flow.<br />

Parameter Modes<br />

The SpO 2 parameter is in offline mode upon power-up. The<br />

parameter automatically switches from offline to ready mode<br />

when a sensor is connected to the Monitor. The parameter<br />

automatically switches from ready to operate mode when<br />

pulses are detected.<br />

93


If a SpO 2 SENSOR OFF FINGER or SPO 2 LOST PULSE alarm<br />

is acknowledged, the parameter automatically switches from<br />

operate to ready mode. If a SpO 2 SENSOR DISCONNECTED<br />

alarm is acknowledged, the parameter automatically<br />

switches from operate to offline mode.<br />

Note: Once either of these alarms have been acknowledged<br />

and the parameter switches to ready mode, SpO 2 monitoring<br />

is not resumed until a valid pulse is detected again.<br />

User Settings<br />

Limit settings<br />

There are two limit settings associated with this parameter:<br />

HIGH and LOW. The range for HIGH is 21 to 100%. The<br />

range for LOW is 20 to 99%. The settings appear in<br />

increments of 1%.<br />

Menu Settings<br />

The PULSE VOLUME menu setting is associated with the<br />

SpO 2 parameter. This option lets you adjust the volume of<br />

the tone that sounds for each pulse detected. It can be<br />

adjusted from 0 - 10 (10 being the loudest). If you set the<br />

volume to zero, no tone will sound.<br />

Sounds Associated with SpO 2<br />

An audible tone is provided by the Monitor for each pulse<br />

detected by the MASIMO SET ® SpO 2 parameter. The pitch<br />

of the audible tone is directly related to the calculated<br />

saturation value. As the saturation value increases, the pitch<br />

frequency increases. As the saturation value decreases, the<br />

pitch frequency decreases. This audible tone is silenced<br />

while an alarm sounds or the PULSE VOLUME is set to 0.<br />

Refer to “Menu Settings” in this section.<br />

Procedures<br />

1. Select a sensor that is appropriate for the patient and the<br />

clinical situation.<br />

Warning: Do not use a damaged sensor or one with<br />

exposed electrical contacts.<br />

Note: Use only MASIMO ® sensors, which are available<br />

from Masimo ® Corporation and GE <strong>Medical</strong> Systems -<br />

Accessories and Supplies.<br />

94


MASIMO SET® SpO2 2. Following the directions for use supplied with the sensor,<br />

apply the sensor to the patient.<br />

Warnings<br />

Patient safety:<br />

• If you fail to apply the sensor properly, the patient’s<br />

skin could be injured or the ability of the <strong>ProCare</strong><br />

Monitor to measure oxygen saturation could be<br />

compromised. For example, a clip-on sensor should<br />

never be taped shut. Taping the sensor could damage<br />

the patient’s skin or impair the venous return, thus<br />

causing venous pulsation and inaccurate measurement<br />

of oxygen saturation.<br />

• Excessive pressure from the sensor may cause necrosis<br />

of the skin.<br />

Monitor performance:<br />

•When an SpO2 sensor is on a limb that has a blood<br />

pressure cuff, the SpO2 data will not be valid when the<br />

cuff is inflated. If SpO2 readings are required during<br />

the entire blood pressure determination, attach the<br />

SpO2 sensor to the limb opposite the one with the<br />

blood pressure cuff.<br />

• Remove nail polish and artificial nails. Placing a sensor<br />

on a polished or an artificial nail may affect accuracy.<br />

Cautions<br />

Patient safety:<br />

• Do not place any clip-on sensor in a patient’s mouth or<br />

on a patient’s nose or toe.<br />

• Do not place a clip-on finger sensor on a patient’s<br />

thumb or across a child’s foot or hand.<br />

• Observe the sensor site to assure adequate distal<br />

circulation. Sensor sites should be checked at least<br />

every 2 hours and rotated at least every 4 hours.<br />

Monitor performance:<br />

• Placing a sensor distal to an arterial line may interfere<br />

with adequate arterial pulsation and compromise the<br />

measurement of SpO2. • Place the sensor so that the LEDs and the photodiode<br />

are opposite each other.<br />

95


3. Plug the SpO 2 sensor into the SpO 2 sensor extension<br />

cable. Then plug the SpO 2 sensor extension cable into the<br />

SpO 2 sensor connector.<br />

4. Proceed with monitoring. SpO 2 determinations run<br />

continuously and can run simultaneously with other<br />

measurements.<br />

Alarms<br />

Alarm Acknowledgeable<br />

by pressing Silence?<br />

SPO2 HIGH no<br />

SPO2 LOW no<br />

E20: SPO2 SENSOR DISCONNECTED yes<br />

E22: SPO2 REPOSITION SENSOR yes<br />

E23: SPO2 SENSOR OFF FINGER yes<br />

E25: SPO2 LOST PULSE no<br />

96


MASIMO SET® SpO 2<br />

Troubleshooting<br />

This section discusses potential difficulties and suggestions<br />

for resolving them. If the difficulty persists, contact a qualified<br />

service person or your local representative.<br />

The service manual, which is for use by qualified service<br />

personnel provides additional troubleshooting information.<br />

PROBLEM: The pulse amplitude bar indicates a pulse, but no<br />

oxygen saturation or pulse rate values appear on the screen.<br />

CAUSE:<br />

• Excessive patient motion may be making it impossible<br />

for the SpO2 function to find a pulse pattern.<br />

• The sensor may be damaged.<br />

• The patient’s perfusion may be too low to allow the<br />

SpO2 function to measure saturation and pulse rate.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

SpO2 sensor is applied securely and properly, and<br />

replace it if necessary; move the sensor to a new site; or<br />

use a disposable adhesive sensor that may tolerate more<br />

motion.<br />

• Replace the sensor.<br />

PROBLEM: The SpO2 value or the pulse rate changes<br />

rapidly; the pulse amplitude bar is erratic.<br />

CAUSE:<br />

• Excessive patient motion may be making it impossible<br />

for the SpO2 function to find a pulse pattern.<br />

• An electrosurgical unit (ESU) may be interfering with<br />

performance.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

sensor is applied securely and properly, and replace it if<br />

necessary; move the sensor to a new site; use a sensor<br />

that tolerates more motion.<br />

97


If an ESU is interfering:<br />

• Move the SpO2 cable as far from the ESU as possible.<br />

• Plug the Monitor and the ESU into different AC circuits.<br />

• Move the ESU ground pad as close to the surgical site as<br />

possible.<br />

• The sensor may be damp or may need to be replaced<br />

with a new sensor.<br />

PROBLEM: The oxygen saturation measurement does not<br />

correlate with the value calculated from a blood gas<br />

determination.<br />

CAUSE:<br />

•The SpO2 calculation may not have correctly adjusted<br />

for the effects of pH; temperature; CO2 ; fetal<br />

hemoglobin; or 2,3-DPG.<br />

• Accuracy can be affected by incorrect sensor application<br />

or use; intravascular dyes; bright light; excessive patient<br />

movement; venous pulsations; electrosurgical<br />

interference; and placement of a sensor on an extremity<br />

that has a blood pressure cuff, arterial catheter, or<br />

intravascular line.<br />

SOLUTION:<br />

• Check that calculations have been corrected<br />

appropriately for the relevant variable. In general,<br />

calculated saturation values are not as reliable as direct<br />

laboratory co-oximeter measurements.<br />

• If there is excessive light, cover the sensor with opaque<br />

material.<br />

• Circulation distal to the sensor site should be checked<br />

routinely. The site must be inspected every 8 hours to<br />

ensure adhesion, skin integrity, and correct optical<br />

alignment. If skin integrity changes, move the sensor to<br />

another site.<br />

• Try to keep the patient still, or change the sensor site to<br />

one with less motion.<br />

• Observe all instructions, warnings, and cautions in this<br />

manual and in the directions for use of the sensor.<br />

98


MASIMO SET® SpO2 PROBLEM: A valid SpO2 signal was present but has<br />

disappeared.<br />

CAUSE:<br />

• A BP determination on the same limb is in progress.<br />

SOLUTION:<br />

• An alarm message code appears on the screen, and the<br />

audible alarm will sound immediately.<br />

PROBLEM: A REPOSITION SENSOR error code has<br />

occurred.<br />

CAUSE:<br />

• Weak or “noisy” signal.<br />

SOLUTION:<br />

Check the patient.<br />

• If possible, keep the patient still; check whether the<br />

sensor is applied securely and properly, and replace it if<br />

necessary; move the sensor to a new site; or replace the<br />

sensor.<br />

• Change sensor type.<br />

• Consider increasing perfusion using heat.<br />

• If there is excessive light, cover the sensor with opaque<br />

material.<br />

99


Specifications<br />

Measurement Range<br />

SpO 2<br />

100<br />

1 to 100%<br />

Pulse Rate 25 to 240 beats/min<br />

Perfusion Range 0.02 to 20%<br />

Accuracy and Motion Tolerance<br />

Saturation<br />

Without Motion - Adult/Ped* 70 to 100% ±2 digits<br />

Without Motion - Neonate* 70 to 100% ±3 digits<br />

With Motion - Adult/Ped/Neo**†70 to 100% ±3 digits<br />

Low Perfusion‡ 70 to 100% ±2 digits<br />

0 to 69% unspecified<br />

Pulse Rate<br />

Without Motion 25 to 240 beats/min ±3 digits<br />

With Motion normal physiologic range<br />

25 to 240 beats/min ±5 digits<br />

* The Masimo SET ® SpO 2 parameter with LNOP-Adt sensors has been validated for<br />

no motion accuracy in human blood studies on healthy adult volunteers in induced<br />

hypoxia studies in the range of 70-100% SpO 2 against a laboratory co-oximeter and<br />

ECG monitor. This variation equals plus or minus one standard deviation. Plus or<br />

minus one standard deviation encompasses 68% of the population.<br />

**The Masimo SET ® SpO 2 parameter with LNOP-Adt sensors has been validated<br />

for motion accuracy in human blood studies on healthy adult volunteers in<br />

induced hypoxia studies while performing rubbing and tapping motions at 2 to 4<br />

Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1 to 5 Hz at<br />

an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100%<br />

SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals<br />

plus or minus one standard deviation. Plus or minus one standard deviation<br />

encompasses 68% of the population.<br />

†The Masimo SET ® SpO 2 parameter with LNOP-Neo Pt sensors has been<br />

validated for neonatal motion accuracy in human blood studies on neonates<br />

while moving the neonate’s foot at 2 to 4 cm against a laboratory co-oximeter<br />

and ECG monitor. This variation equals plus or minus, one standard deviation.Plus<br />

or minus one standard deviation encompasses 68% of the population.<br />

‡The Masimo SET ® SpO 2 parameter has been validated for low perfusion<br />

accuracy in bench top testing against a Biotek Index 2 stimulator and Masimo’s<br />

simulator with signal strengths of greater than 0.02% and a % transmission of<br />

greater than 5% for saturations ranging from 70 to 100%. This variation equals<br />

plus or minus, one standard deviation.Plus or minus one standard deviation<br />

encompasses 68% of the population.


MASIMO SET® SpO 2<br />

Masimo ® Sensor Accuracy<br />

Sensor Model SpO2 Range<br />

70% - 100%<br />

LNOP<br />

LNOP-ADT ± 2 digits<br />

LNOP-ADT Long ± 2 digits<br />

LNOP-PDT ± 2 digits<br />

LNOP-NEO ± 3 digits<br />

LNOP-NEO PT ± 3 digits<br />

LNOP-DCI (reusable) ± 2 digits<br />

LNOP-DCSC (reusable) ± 2 digits<br />

LNOP-DCIP (reusable) ± 2 digits<br />

NRI25 (reusable) ± 2 digits<br />

Resolution<br />

Saturation (% SpO 2 ) 1%<br />

Pulse Rate (bpm) 1<br />

Low Perfusion Performance<br />

>0.02% Pulse Amplitude Saturation (% SpO 2) ±2 digits<br />

and % Transmission >5% Pulse Rate ±3 digits<br />

Interfering Substances<br />

Carboxyhemoglobin may erroneously increase readings. The<br />

level of increase is approximately equal to the amount of<br />

carboxyhemoglobin present. Dyes, or any substance<br />

containing dyes, that change usual arterial pigmentation may<br />

cause erroneous readings.<br />

Sensor Light Source<br />

Wavelength Infrared: 905 nm (nominal)<br />

Red: 660 nm (nominal)<br />

Power Dissipation Infrared: 22.5 mW (max)<br />

Red: 27.5 mW (max)<br />

101


Factory Default Settings<br />

SpO 2 (%) HIGH: 100<br />

SpO 2 (%) LOW: 90<br />

Sensitivity Mode 2 (for low perfusion-Default)<br />

Averaging Time 12 seconds<br />

FastSAT Mode 0 (for Off)<br />

Masimo Patents<br />

5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644;<br />

5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830;<br />

6,157,850, and international equivalents.<br />

102


TURBOTEMP


104


TURBOTEMP<br />

Description<br />

The Temperature parameter is included in Models 200 and<br />

400. The <strong>ProCare</strong> Monitor uses IVAC ® TURBOTEMP<br />

technology and can be used with both oral and rectal<br />

temperature probes. The TURBOTEMP parameter<br />

consists of an electronic thermometer that uses a<br />

temperature-sensing device known as a thermistor. The<br />

thermistor is part of the electrical circuit and is located at<br />

the tip of the probe. To obtain temperatures, the probe tip<br />

measures the rate of change in temperature when the<br />

thermistor comes into contact with surrounding tissue. A<br />

final temperature is calculated based on this rate of change.<br />

Temperature values are shown in the Temperature<br />

window in degrees Celsius or Fahrenheit, and the unit of<br />

measure is indicated by the °C °F display. The default,<br />

which is Fahrenheit, must be changed in the Configuration<br />

mode. Once in Config mode, Unt (abbreviation for unit)<br />

appears in the Temperature window; select either ° C or ° F.<br />

Two modes of operation are available: predictive and monitor.<br />

Predictive Mode<br />

In predictive mode, a final temperature is displayed and an<br />

audible single tone sounds. Upon initiation of a<br />

measurement, the previous temperature measurement, if<br />

present, is cleared. A predictive measurement is initiated<br />

when the probe is removed from the probe holster. A<br />

predictive mode measurement is terminated when one of<br />

the following occurs:<br />

• A final value is determined.<br />

• The probe is inserted into the probe holster.<br />

• The temperature measurement mode is automatically<br />

switched to monitor mode because a predictive result<br />

could not be determined.<br />

• A Temperature alarm is issued.<br />

A predictive temperature measurement value is<br />

automatically cleared after 2 minutes if the probe is stored<br />

*IVAC ® and TURBOTEMP are trademarks of ALARIS <strong>Medical</strong> Systems<br />

105


in the probe holster or after 5 minutes when the probe is left<br />

out of the probe holster.<br />

Monitor Mode<br />

Monitor mode is most commonly used for axillary<br />

temperature determinations. In monitor mode, the display is<br />

updated continually as the patient’s temperature rises or falls.<br />

Monitor mode is automatically initiated when the probe is<br />

removed from the probe holster twice within a half of a<br />

second (remove probe from holster, reinsert probe tip into<br />

holster, remove probe from holster) or when a predictive<br />

mode measurement terminates after approximately 1 minute<br />

of not being able to successfully compute a result. When in<br />

monitor mode, the temperature value flashes. When the<br />

temperature parameter switches from predictive mode to<br />

monitor mode, a tone sounds. Monitor mode is terminated<br />

when the probe is inserted into the probe holster.<br />

Note: These temperature readings are not stored in history,<br />

printed, or reported via host comms.<br />

General Warning<br />

• The performance of the Monitor may be degraded if it<br />

is operated outside of the environmental conditions<br />

specified in Product Overview.<br />

General Cautions<br />

• Be careful not to overextend the coiled cord of the<br />

temperature probe. Overextension can damage the<br />

probe coil connector interfaces.<br />

• Accurate oral temperatures can only be obtained by<br />

placing the blue probe under the tongue in the right or<br />

left sublingual pocket. Temperatures in other locations in<br />

the mouth can vary by more than 2° F or 1° C.<br />

• Accurate rectal temperatures can only be obtained by<br />

using the red temperature probe. Red and blue<br />

temperature probes are not interchangeable.<br />

• Do not allow the tip of the predictive temperature<br />

probe to come into contact with a heat source (e.g.,<br />

hands or fingers) prior to taking a temperature<br />

measurement. If this occurs, allow 5 seconds for the<br />

probe tip to cool before proceeding.<br />

106


TURBOTEMP<br />

• Use only IVAC ® probes and P850A probe covers. The<br />

size, shape, and thermal characteristics of the probe<br />

covers can affect the performance of the instrument.<br />

Inaccurate readings may occur unless IVAC ® probes<br />

and probe covers are used.<br />

• Electromagnetic Compatibility: Operating the<br />

thermometer near equipment which radiates highenergy<br />

electromagnetic and radio frequencies<br />

(electrosurgical/cauterizing equipment, portable<br />

radios, cellular telephones, etc.) may cause false alarm<br />

conditions. If this happens, reposition the thermometer<br />

away from the source of interference and perform a<br />

new measurement.<br />

• If a patient’s temperature is below 96.0° F (35.6° C), the<br />

unit will automatically switch from the normal mode into<br />

the monitor mode within 10 seconds. It will continue to<br />

monitor the patient’s temperature until the probe is<br />

removed from the patient and returned to the storage well.<br />

Configuration Settings Associated with Temperature<br />

There is one configuration setting associated with this<br />

parameter: Unit of Measure (Unt). This setting allows you to<br />

choose ° Fahrenheit (F) or ° Celsius (C).<br />

Buttons Associated with Temperature<br />

There are no buttons associated with this parameter.<br />

Windows Associated with Temperature<br />

The Temperature window displays the value in ° C or ° F.<br />

Indicators Associated with Temperature<br />

The indicators associated with Temperature are ° C or ° F.<br />

Measurement in Progress Indicators<br />

Predictive Mode<br />

•A single dash appears in the left-side of the<br />

Temperature window indicating use of an oral probe.<br />

107


•Two dashes appear in the left-side of the Temperature<br />

window indicating use of a rectal probe.<br />

•A “chase sequence” of dashes around the outside of<br />

the right-most digit of the Temperature window appears<br />

indicating that the probe is in contact with skin.<br />

Monitor Mode<br />

•The temperature value flashes indicating monitor<br />

mode.<br />

•Four dashes flash in the Temperature window<br />

indicating that the measurement is < 80.0°F.<br />

Measurement NOT in Progress Indicators<br />

•Two dashes appear in the center of the Temperature<br />

window indicating no values are present, and the probe<br />

is connected.<br />

•Blank: The Temperature window appears blank<br />

indicating that no probe is connected.<br />

108


TURBOTEMP<br />

Parameter Modes<br />

The TURBOTEMP parameter is in operate mode upon<br />

power-up. It does not have a ready mode.<br />

User Settings<br />

There are no user settings associated with this parameter.<br />

Menu Settings<br />

There are no menu settings associated with this parameter.<br />

Sounds Associated with TURBOTEMP<br />

There are three sounds associated with the TURBOTEMP<br />

parameter.<br />

• Single tone: sounds whenever a temperature probe is<br />

removed from or inserted into the probe holster.<br />

• Double tone: sounds whenever monitor mode is<br />

activated.<br />

• Triple tone: sounds at the completion of a predictive<br />

temperature measurement that results in a final value.<br />

Procedures for Oral Predictive Mode Determinations<br />

For oral temperature measurement, use the blue oral probe.<br />

1. Connect the temperature probe cable to the temperature<br />

probe connector.<br />

2. Holding the sides of the probe button, remove the<br />

temperature probe from the probe holster. An audible<br />

single-tone sounds. Place a protective temperature probe<br />

cover on the probe.<br />

3. Have the patient open his/her mouth and carefully insert<br />

the probe tip deep into the sublingual pocket where the<br />

richest blood supply is located. Failure to firmly install the<br />

probe cover may result in the probe cover becoming<br />

loose or disengaged during use. Be careful not to press<br />

the probe ejection button where the cord exits the probe<br />

as this might loosen or eject the probe cover.<br />

109


4. Hold the probe steady during the entire temperature<br />

measurement process, and keep the probe tip in contact<br />

with the tissue at all times. Do not allow the patient to<br />

reposition the probe.<br />

5. The determination begins automatically and takes<br />

approximately 10 seconds, during which time a “chase<br />

sequence” in the right-side of the Temperature window<br />

appears to indicate progress.<br />

6. When the determination is complete, an audible triple<br />

tone sounds and the temperature appears on the display.<br />

7. Remove the probe. Discard the disposable cover by<br />

holding the probe as you<br />

would a syringe and pressing<br />

the button on the probe<br />

handle. Place the probe in the<br />

probe holster. An audible<br />

single-tone sounds. Once you<br />

place the probe in the probe<br />

holster, the temperature<br />

values will be cleared in 2<br />

minutes. They are cleared<br />

after 5 minutes when the probe is left out of the probe<br />

holster.<br />

Procedures for Rectal Predictive Mode Determinations<br />

For rectal temperature measurement use the red rectal probe.<br />

1. Connect the temperature probe cable to the temperature<br />

probe connector.<br />

2. Remove the temperature probe from the probe holster.<br />

An audible single-tone sounds. Place a protective<br />

temperature probe cover on the probe. Failure to firmly<br />

110


TURBOTEMP<br />

install the probe cover may result in the probe cover<br />

becoming loose or disengaged during use. Be careful not<br />

to press the probe ejection button where the cord exits<br />

the probe as this might loosen or eject the probe cover.<br />

3. Touch the tissue about a half inch (1.3 cm) above the<br />

sphincter muscle and carefully insert the probe, using<br />

current hospital technique for penetration. (The use of a<br />

lubricant is optional.)<br />

4. The determination begins automatically. To ensure<br />

continuous tissue contact and maximize patient comfort,<br />

hold the probe in position until the determination is<br />

complete. This takes approximately 10 seconds, during<br />

which time a “chase sequence” in the right-side of the<br />

Temperature window appears to indicate progress.<br />

5. When the determination is complete, an audible tripletone<br />

sounds and the temperature appears on the display.<br />

6. Remove the probe. Discard the disposable cover by<br />

holding the probe as you would a syringe and pressing<br />

the button on the probe handle. Place the probe in the<br />

probe holster. An audible single-tone sounds. Once you<br />

place the probe in the probe holster, the temperature<br />

values will be cleared in 2 minutes. They are cleared after<br />

5 minutes when the probe is left out of the probe holster.<br />

.<br />

Procedures for Monitor Mode Determinations<br />

(Axillary Determinations)<br />

1. Connect the temperature probe cable to the temperature<br />

probe connector.<br />

2. For accurate axillary<br />

measurement, the Monitor<br />

must be set in monitor mode.<br />

To trigger monitor mode,<br />

remove the probe from the<br />

probe holster, then reinsert the<br />

probe tip and remove it again<br />

within a half of a second<br />

(remove probe from holster,<br />

reinsert probe tip into holster, remove probe from<br />

holster). An audible tone sounds each time you remove<br />

the probe from the probe holster. When monitor mode is<br />

activated, an audible double-tone sounds and flashing<br />

numbers appear in the Temperature window. Place a<br />

111


protective temperature probe cover on the probe and<br />

insert the probe in the patient's axilla, making sure the tip<br />

of the probe is in contact with the skin and positioned as<br />

close as possible to the axillary artery with the patient's<br />

arm held close to his/her side.<br />

3. Leave the probe in place for the same length of time as<br />

required by standard hospital procedure for taking an<br />

axillary temperature. The Monitor does not beep to<br />

indicate a final reading.<br />

4. Remove the probe. Discard the disposable cover by<br />

holding the probe as you would a syringe and pressing<br />

the button on the probe handle. Place the probe in the<br />

probe holster. An audible single-tone sounds. Once you<br />

place the probe in the probe holster, the temperature<br />

values will be cleared immediately.<br />

Notes<br />

• If there is a long delay from the time the probe is<br />

removed from the probe holster until it is inserted into<br />

the patient’s mouth, it is possible that the instrument will<br />

not display a final temperature. If this occurs, insert the<br />

probe into the probe holster, remove it again, and start a<br />

new measurement.<br />

• If an alarm is actively sounding, an audible tone will not<br />

sound.<br />

• If the probe is not inserted/placed within 40 seconds of<br />

probe removal, Monitor mode will be entered.<br />

• If the probe tip temperature is 92.0° F or higher (33.3° C)<br />

or 60° F (15.6° C) or lower when taken out of the probe<br />

holster, the thermometer will not be able to perform a<br />

predictive measurement. Instead, the thermometer will<br />

automatically go into monitor mode. The temperature<br />

reading will then flash. A correct final temperature<br />

reading may require 3 minutes or longer. The Monitor<br />

will not beep at final temperature. It will continue to<br />

monitor the patient’s temperature until the probe is<br />

removed from the patient and returned to the probe<br />

holster.<br />

112


TURBOTEMP<br />

Alarms<br />

Alarm Acknowledgeable<br />

by pressing Silence?<br />

E63: TEMP DISCONNECTED yes<br />

E61: TEMP PROBE BROKEN no<br />

E66: TEMP PROBE TOO HOT no<br />

113


114


TURBOTEMP<br />

Specifications<br />

Scale °Fahrenheit (F)<br />

°Celsius (C)<br />

Range<br />

Predictive mode Max: 41.1° C; 106.0° F<br />

Min: 35.6° C; 96.0° F<br />

Monitor mode Max: 41.1° C; 106.0° F<br />

Min: 26.7° C; 80.0° F<br />

Monitor mode accuracy ± 0.1° C<br />

± 0.2° F (when tested in a<br />

calibrated liquid bath; meets<br />

ASTM E1112, Table 1, in range<br />

specified)<br />

Determination time approx. 10 seconds, typical<br />

Use only IVAC ® probes and P850A probe covers. The size,<br />

shape, and thermal characteristics of the probe covers can<br />

affect the performance of the instrument. Inaccurate<br />

readings or retention problems may occur unless IVAC ®<br />

probes and probe covers are used. Refer to Appendix D for<br />

reorder codes.<br />

Factory Default Settings<br />

Unit of measure ° F<br />

IVAC ® Patents<br />

U.S. D300,728, D300,909<br />

115


116


Pulse Rate


118


119<br />

Pulse Rate<br />

Description<br />

The Pulse Rate parameter is included in all Models. Pulse<br />

Rate values can be derived from one of two sources. In<br />

descending order of priority, they are pulse oximetry (SpO 2)<br />

and noninvasive blood pressure (BP). The derived values for<br />

Pulse Rate appear in the Pulse Rate window.<br />

While SpO 2 is in operate mode, SpO 2 is the primary source<br />

of the Pulse Rate. At any time while SpO 2 is the source and it<br />

is unable to publish a value for Pulse Rate, three dashes (- - -)<br />

are displayed in Pulse Rate window.<br />

BP is the secondary source of Pulse Rate. Upon completion<br />

of a BP determination, a Pulse Rate value is displayed in the<br />

Pulse Rate window. A Pulse Rate value is displayed as long<br />

as the results of that determination are displayed or until<br />

SpO2 switches to operate mode.<br />

Note: When BP is in STAT mode and is the source of Pulse<br />

Rate, the Pulse Rate value is not checked against its limits<br />

upon completion of the determination.<br />

When SpO 2 and BP are in operate mode, their associated<br />

alarms affect their availability to act as the Pulse Rate source.<br />

General Notes<br />

• Because the various sources measure or derive Pulse<br />

Rate differently from each other, when the Monitor<br />

changes from one source to another the value in the<br />

Pulse Rate field may change.<br />

• A patient’s vital signs may vary dramatically during the<br />

use of cardiovascular agents such as those that raise or<br />

lower blood pressure or those that increase or decrease<br />

heart rate.<br />

• If an SpO2-derived pulse rate is erratic, the pulse<br />

oximeter parameter may be unable to measure the pulse<br />

and may cause an alarm.<br />

Buttons Associated with Pulse Rate<br />

There are no buttons associated with this parameter.


Windows Associated with Pulse Rate<br />

The Pulse Rate window displays the Pulse Rate value in<br />

beats per min (bpm).<br />

Indicators Associated with Pulse Rate<br />

The indicators associated with Pulse Rate are HIGH and<br />

LOW. Refer to ”Limit Settings” in this section.<br />

Parameter Modes<br />

The Pulse Rate parameter is in operate mode upon powerup.<br />

It does not have a ready mode.<br />

User Settings<br />

Limit settings<br />

There are two limit settings associated with this parameter:<br />

HIGH and LOW. Monitors with NELLCOR ® Technology: The<br />

range for HIGH is 35 to 250 bpm. The range for LOW is 30<br />

to 245 bpm. Monitors with MASIMO ® Technology: The<br />

range for HIGH is 35 to 235 bpm. The range for LOW is 30<br />

to 230 bpm.The settings appear in increments of 5 bpm.<br />

Menu Settings<br />

If SpO 2 is the source, the PULSE VOLUME menu setting is<br />

associated with this parameter. This option lets you adjust<br />

the volume of the pulse tones that are generated when SpO 2<br />

is the source. It can be adjusted from 0 - 10 (10 being the<br />

loudest). If you set the volume to zero, no tone will sound.<br />

Sounds Associated with Pulse Rate<br />

If SpO 2 is the source, there is one sound associated with this<br />

parameter: a beat detected sound. A Pulse Rate tone is<br />

indicated by an audible beep each time a beat is detected by<br />

the SpO 2 parameter.<br />

Note: When the pulse rate is derived from BP, there is no<br />

audible pulse beat.<br />

120


121<br />

Pulse Rate<br />

Alarms<br />

Alarm Acknowledgeable<br />

by pressing Silence?<br />

PULSE RATE HIGH no-SpO 2, yes-BP<br />

PULSE RATE LOW no-SpO 2, yes-BP<br />

SpO 2 Associated Alarms (If SpO 2 is the source):<br />

E25: SPO 2 LOST PULSE<br />

E20: SPO 2 SENSOR DISCONNECTED<br />

E21: REPLACE SENSOR<br />

BP Associated Alarms (If BP is the source):<br />

E89: BP NO DETERMINATION<br />

E85: BP LEVEL TIMEOUT<br />

E84: BP TOTAL TIMEOUT<br />

E83: BP PUMP TIMEOUT<br />

E80: BP OVERPRESSURE<br />

E82: EXCESS AIR IN CUFF


Specifications<br />

Factory Default Settings<br />

Pulse Rate HIGH: 150<br />

LOW: 50<br />

Refer to individual SpO 2 and BP sections.<br />

122


Appendix A:<br />

Principles of Noninvasive<br />

Blood Pressure<br />

Determination


124


125<br />

Appendix A<br />

Principles of Noninvasive Blood Pressure<br />

Determination<br />

The oscillometric method of determining NIBP is<br />

accomplished by a sensitive transducer, which measures cuff<br />

pressure and minute pressure oscillations within the cuff. The<br />

first determination sequence initially pumps up to a cuff<br />

pressure of about 160 mmHg for adult/pediatric patients or<br />

110 mmHg for neonates depending on initial target pressure<br />

preset. After inflating the cuff, the Monitor begins to deflate it<br />

and measures systolic pressure, mean arterial pressure, and<br />

diastolic pressure. When the diastolic pressure has been<br />

determined, the Monitor finishes deflating the cuff and<br />

updates the screen.<br />

The Monitor deflates the cuff one step each time it detects<br />

two pulsations of relatively equal amplitude. The time<br />

between deflation steps depends on the frequency of these<br />

matched pulses (pulse rate of the patient). However, if the<br />

Monitor is unable to find any pulse within several seconds, it<br />

will deflate to the next step. The process of finding two<br />

matched pulses at each step provides artifact rejection due<br />

to patient movement and greatly enhances the accuracy of<br />

the Monitor. The figure shows the NIBP determination<br />

sequence.<br />

NIBP Determination Sequence<br />

At each step the microprocessor stores cuff pressure, the<br />

matched pulse amplitude, and the time between successive<br />

pulses. The stepped deflation and matched pulse detection


continues until diastolic pressure is determined or total cuff<br />

pressure falls below 7 mmHg. The Monitor then deflates the<br />

cuff (to zero detected pressure), analyzes the stored data,<br />

and updates the screen.<br />

The operating cycle is composed of four parts: inflation time,<br />

deflation time, evaluation time, and wait time. Wait time,<br />

which varies from mode to mode, is affected by the cycle<br />

time (auto mode) or operator intervention (manual mode).<br />

The figure shows the basic operating cycle.<br />

NIBP Operating Cycle<br />

Systolic Search<br />

If systolic pressure is not found, the Monitor can search at<br />

cuff pressures higher than the initial target pressure. If the<br />

determination is in a late stage, the Monitor will inflate the<br />

cuff to 70 mmHg above the initial target pressure to get<br />

better data in the systolic region. If the determination is in an<br />

early stage, the Monitor will inflate the cuff to 50 mmHg<br />

above the initial target pressure. The maximum pressure<br />

allowed in systolic search is limited by the normal range for<br />

cuff pressures.<br />

In any operating mode, if a patient's systolic pressure<br />

exceeds the inflation pressure of the monitor, the Monitor<br />

will begin normal deflation sequence, detect the absence of<br />

126


127<br />

Appendix A<br />

a systolic value, stop deflation, reinflate to a higher (than<br />

initial) inflation pressure (290 mmHg maximum), and resume<br />

normal deflation sequence. This additional inflation will occur<br />

only once per determination.<br />

If a previous valid systolic pressure is displayed and less than<br />

2 minutes old, and the new systolic pressure oscillations are<br />

compared with the previous valid determination and the<br />

Monitor "thinks" that the systolic was not obtained, the<br />

Monitor will inflate the cuff to a pressure of an additional 50<br />

mmHg above the immediately preceding inflation. This<br />

additional inflation will occur only once per determination.<br />

Reference Used to Determine NIBP Accuracy<br />

To establish accuracy of an NIBP device, manufacturers have<br />

used several different types of references. The reference<br />

blood pressures may be obtained by invasive pressure<br />

monitoring at the central aortic region or at the radial sites.<br />

The reference blood pressures may also be obtained by<br />

noninvasive methods like auscultatory method (using cuff<br />

and stethoscope).<br />

Note: For neonatal populations, the reference is always the<br />

intra-arterial pressure monitoring method.<br />

DINAMAP ® Monitors With Intra-Arterial Reference<br />

(DINAMAP ® Classic Technology)<br />

For these monitors, the NIBP is referenced to the invasive<br />

blood pressure obtained at the central aortic region.<br />

DINAMAP ® Monitors With Auscultatory Reference<br />

(DINAMAP ® Auscultatory Technology)<br />

In these monitors, the reference blood pressure is the<br />

auscultatory method for adult and pediatric populations. For<br />

neonatal populations, the reference is the invasive blood<br />

pressure obtained at the central aortic region.<br />

Caution: Do not use an infant cuff with an auscultatory<br />

reference DINAMAP ® <strong>ProCare</strong> Monitor. The neonatal #5<br />

cuff and neonatal hose may be used on patients with an<br />

arm circumference of 8 - 15 cm.


128


Appendix B:<br />

Maintenance


130


*Trademark<br />

131<br />

Appendix B<br />

Maintenance<br />

Cleaning the Monitor<br />

The Monitor and accessories are to be kept clean and used<br />

according to the instructions provided here and in the<br />

Service Manual.<br />

The exterior of the Monitor may be wiped clean with a soft<br />

cloth slightly dampened with mild detergents. The Monitor<br />

and accessories should be inspected once yearly for wear<br />

and damage.<br />

•Do not immerse unit.<br />

•Do not clean with isopropyl alcohol or other solvents.<br />

•Do not immerse hoses.<br />

Cuff Cleaning and Disinfection<br />

General<br />

The cuff must be thoroughly cleaned with the specified<br />

detergent before reuse. The additional use of household<br />

bleach as described below provides at least intermediatelevel<br />

disinfection.<br />

• Apply cuff hose plugs before cleaning.<br />

• The following cleansing procedure was repeated 20<br />

times on DURA-CUF ® Blood Pressure Cuffs and once on<br />

SOFT-CUF ® Blood Pressure Cuffs without affecting the<br />

performance of the cuff.<br />

• While this procedure is adequate for cleaning/<br />

disinfection, it may not remove all stains.<br />

•Do not immerse hoses.<br />

•Do not immerse cuffs without prior application of cuff<br />

hose caps.<br />

Materials<br />

• Enzymatic detergent such as ENZOL* enzymatic<br />

detergent (US) or Cidezyme* enzymatic detergent (UK)<br />

• Distilled water<br />

• 10% solution of household bleach (5.25% sodium<br />

hypochlorite) in distilled water<br />

• Soft cloths and soft-bristled brushes


•Spray bottles<br />

Procedure<br />

1. Prepare the enzymatic detergent according to the<br />

manufacturer’s instructions and the 10% bleach solution,<br />

in separate spray bottles.<br />

2. Spray the detergent liberally on device. If the material is<br />

dried on, allow the cuff to sit for 1 minute. For soil on the<br />

soft part of the closure or the cuff itself, wipe the material<br />

off with a soft cloth. For persistent contamination on the<br />

soft part of the closure, use a soft-bristled brush to loosen<br />

particles. Rinse with copious amounts of distilled water.<br />

Repeat until no visible contamination remains. For soil on<br />

the hook part of the closure, use a soft-bristled brush to<br />

remove the material, and rinse with copious amounts of<br />

distilled water. Repeat until no visible contamination<br />

remains.<br />

3. Spray the 10% bleach solution on the affected area until<br />

the area is saturated. Allow the cuff to sit for 5 minutes.<br />

4. Wipe away any excess solution and rinse the cuff again<br />

with distilled water. Allow 2 hours for drying.<br />

The user has the responsibility to validate any deviations<br />

from the recommended method of cleaning and disinfection.<br />

For additional information on infection control procedures,<br />

contact GE <strong>Medical</strong> Systems Information Technologies<br />

Technical Support.<br />

Temperature Devices<br />

Do not immerse predictive temperature probes. The probe<br />

may be cleaned with a solution of 10% bleach in water. Use<br />

a cloth or sponge—just damp, not wet—and avoid getting any<br />

liquid into the interior of the probe.<br />

SpO 2 Sensors<br />

Adhesive sensors are sterile and for single use only. Reusable<br />

sensors should be cleaned before reuse with a 70% alcohol<br />

solution. If low-level disinfection is required, use a 1:10<br />

bleach solution. Do not use undiluted bleach (5% - 5.25%<br />

sodium chlorite) or any cleaning solution other than those<br />

recommended here because permanent damage to the<br />

132


133<br />

Appendix B<br />

sensor could occur. Do not sterilize the sensor by irradiation,<br />

steam, or ethylene oxide. If disposable sensors or their<br />

packaging are damaged, they must be disposed of as advised<br />

in this appendix.<br />

To clean or disinfect the sensor:<br />

1. Saturate a clean, dry gauze pad with the cleaning<br />

solution. Wipe all surfaces of the sensor and cable with<br />

this gauze pad.<br />

2. Saturate another clean, dry gauze pad with sterile or<br />

distilled water. Wipe all surfaces of the sensor and cable<br />

with this gauze pad.<br />

3. Dry the sensor and cable by wiping all surfaces with a<br />

clean, dry gauze pad.<br />

Storage and Battery Care<br />

If it becomes necessary to store the Monitor for an extended<br />

period of time, first fully charge then remove the battery.<br />

Then store the Monitor and the battery in the original<br />

packaging materials.<br />

Batteries should always be fully charged before being placed<br />

in storage. Even after 6 months of storage, a fully charged<br />

battery can retain about 80% of its charge. A fully charged<br />

battery in good condition will provide sufficient power to<br />

operate a Monitor for approximately 2 hours, including<br />

temperature and BP measurements made at 5-minute<br />

intervals.<br />

It is best to keep the battery charged as fully as practical and<br />

never store the Monitor with the battery in a discharged<br />

condition. When the battery will no longer hold a charge,<br />

remove and replace it with one of the same part number.<br />

Failure to replace the battery with the same GE <strong>Medical</strong><br />

Systems Information Technologies part number may result in<br />

shorter battery life.<br />

Battery charging will take place as long as the Monitor<br />

remains connected to an external DC power source.


Cautions<br />

• To ensure that the battery will be ready for portable<br />

operation, keep the Monitor connected to a mains<br />

supply whenever possible.<br />

• Repeated failure to fully charge the battery will result in<br />

a significant reduction in battery life.<br />

• The expected lifetime of the battery largely depends on<br />

the way in which the Monitor is used. If the battery is<br />

allowed to completely discharge before being fully<br />

recharged, the battery should survive around 700<br />

charge/discharge cycles.<br />

Replacement batteries may be obtained from GE <strong>Medical</strong><br />

Systems Information Technologies.<br />

Note: The replacement part number of the battery is<br />

633178CR. Do not use other types.<br />

Fuses<br />

The Monitor contains four fuses. The fuses are auto-resetable<br />

and mounted within the Monitor. The fuses protect the low<br />

voltage DC input, the battery, the remote alarm output, and<br />

the +5 V output on the host port connector.<br />

Calibration<br />

Calibration of the BP parameter should be checked at least<br />

once a year or when there is doubt about the validity of the<br />

readings.<br />

Leak Testing<br />

A leak test of the BP parameter should be performed at least<br />

once a year or when there is doubt about the validity of the<br />

pressure readings.<br />

Caution: Refer calibration and leak testing to qualified<br />

service personnel. Full calibration details are available in<br />

the DINAMAP ® <strong>ProCare</strong> Monitor Service Manual,<br />

available from GE <strong>Medical</strong> Systems Information<br />

Technologies.<br />

134


135<br />

Appendix B<br />

Disposal of Product Waste<br />

As you use the <strong>ProCare</strong> Monitor, you will accumulate solid<br />

wastes that require proper disposal or recycling. These<br />

include batteries, patient applied parts, and packaging<br />

material.<br />

Batteries<br />

Caution: Do not incinerate batteries.<br />

The sealed rechargeable battery contains lead and must be<br />

recycled. Discharge this battery prior to disposal. Place the<br />

battery in packaging which electrically isolates its contents.<br />

Do not puncture or place the battery in a trash compactor.<br />

Do not incinerate the battery or expose it to fire or high<br />

temperatures. Recycle in accordance with applicable<br />

regional body controlled guideline.<br />

In the USA, call 1.800.SAV.LEAD for instructions on how to<br />

recycle. For international users, contact your local authorities<br />

on recycling. GE <strong>Medical</strong> Systems Information Technologies<br />

encourages the recycling of lead-acid batteries.<br />

Patient Applied Parts<br />

Certain patient applied parts, such as those with adhesive<br />

(disposable SpO 2 sensors), are intended for single use and<br />

should be disposed of properly as medical waste in<br />

accordance with regional body controlled guideline.<br />

Other patient applied parts, such as blood pressure cuffs,<br />

should be cleaned according to instructions. Inspect reusable<br />

applied parts for wear, replace as necessary, and dispose of<br />

used product as medical waste in accordance with regional<br />

body controlled guideline.<br />

Packaging Material<br />

Retain original packaging materials for future use in storing<br />

or shipping the Monitor and accessories. This<br />

recommendation includes corrugated shippers and inserts.<br />

Whenever possible recycle the packaging of accessories and<br />

patient applied parts.


136


Appendix C:<br />

Connection Details


138


Connection Details<br />

Host Port Connector (rear panel)<br />

139<br />

Appendix C<br />

WARNING! Auxiliary equipment connected to the<br />

DINAMAP ® <strong>ProCare</strong> Monitor will result in the formation of<br />

an electromedical system and thus, must comply with the<br />

requirements of EN 60601-1-1/ IEC 601-1. All host port<br />

signals are NON-ISOLATED and should be connected to<br />

equipment conforming to IEC-601-1, configured to comply<br />

with IEC 601-1-1 ONLY. Where isolation of data<br />

communication is required, GE <strong>Medical</strong> Systems Information<br />

Technologies part number ILC1926 should be used. If<br />

external alarm control is required, GE <strong>Medical</strong> Systems<br />

Information Technologies part number 487208 (Isolated<br />

Remote Alarm Cable Assembly) should ALWAYS be used.<br />

When a high-priority alarm condition is displayed on the<br />

Monitor, the remote alarm signal becomes active within 0.5<br />

seconds. The active state of the alarm signal is an open<br />

circuit. In the inactive state the alarm signal is connected to<br />

ground. Please refer to the Information Sheet included with<br />

the isolated remote alarm cable for operational details.<br />

Note: When using remote alarm, the <strong>ProCare</strong> Monitor should<br />

be considered the primary alarm source. The secondary<br />

alarm is used for secondary purposes only.<br />

Pin # Function<br />

1 Common<br />

2 Inverted TTL Transmit Data<br />

3 Inverted TTL Receive Data<br />

4 +5 volts<br />

5 No connection<br />

6 No connection<br />

7 Common<br />

8 Remote Alarm<br />

9 No connection<br />

10 No connection


11 RS232 Transmit Data (TxD)<br />

12 No connection<br />

13 RS232 Receive Data (RxD)<br />

14 No connection<br />

15 No connection<br />

140


Appendix D:<br />

Warranty, Service,<br />

& Spare Parts


142


143<br />

Appendix D<br />

Warranty, Service, and Spare Parts<br />

Warning: There are no user serviceable parts inside the<br />

DINAMAP ® <strong>ProCare</strong> Monitor. Refer all servicing to<br />

qualified personnel.<br />

Warranty<br />

All repairs on products under warranty must be performed or<br />

approved by GE <strong>Medical</strong> Systems Information Technologies.<br />

Unauthorized repairs will void the warranty.<br />

Products not covered by warranty should be repaired only<br />

by qualified electronics service personnel.<br />

Assistance and Parts<br />

If the product malfunctions or if assistance, service, or spare<br />

parts are required, contact GE <strong>Medical</strong> Systems Information<br />

Technologies Technical Support.<br />

Before contacting GE <strong>Medical</strong> Systems Information<br />

Technologies it is helpful if you can duplicate the problem<br />

and check and confirm the operation of all accessories to<br />

ensure that they are not the cause of the problem.<br />

When calling, please have the following information at hand:<br />

• product name and model number and complete<br />

description of the problem<br />

• the serial number of your Monitor<br />

• your name and address<br />

• a purchase order number if out-of-warranty repairs or<br />

spare parts are required<br />

• your GE <strong>Medical</strong> Systems Information Technologies<br />

account number, if applicable<br />

• the part number(s) for spare or replacement parts


Repairs<br />

If your product requires warranty, extended warranty, or<br />

non-warranty repair service, call GE <strong>Medical</strong> Systems<br />

Information Technologies and a representative will assist you.<br />

To facilitate prompt service in cases where the product has<br />

external chassis or case damage, please advise the<br />

representative when you call.<br />

The representative will record all necessary information and<br />

will provide a Return Authorization Number. Prior to<br />

returning any product for repair, a Return Authorization<br />

Number must be obtained.<br />

Packing Instructions<br />

If you have to return goods for service, follow these<br />

recommended packing instructions:<br />

• Remove all hoses, cables, sensors, power cords, and<br />

ancillary products from the Monitor before packing,<br />

unless you suspect they are associated with the problem.<br />

• Wherever possible use the original shipping carton and<br />

packing materials.<br />

• Observe the environmental conditions detailed in<br />

Product Overview.<br />

It is recommended that all returned goods be insured. Claims<br />

for loss or damage to the product must be initiated by the<br />

sender.<br />

Service Manuals<br />

Service Manuals containing calibration and repair<br />

information can be ordered from GE <strong>Medical</strong> Systems<br />

Information Technologies. These manuals also include<br />

assembly drawings, and spare parts lists. The reorder number<br />

of the Service Manual is 2009381-001.<br />

144


Appendix E:<br />

Reorder Codes


146


Reorder Codes<br />

147<br />

Appendix E<br />

PROD<br />

PRODUCT CODE ECAT<br />

DINAMAP <strong>ProCare</strong> Monitor Operations Manual-English 2009360-001<br />

DINAMAP <strong>ProCare</strong> Monitor Service Manual 2009381-001<br />

Battery 633178CR<br />

Power Convertor US 2009460-001<br />

Power Convertor UK 2008538-001<br />

Power Convertor EUR 2009539-001<br />

Printer Paper (box of 10) 089100 E9050KP<br />

DINAMAP Rolling Stand 003215 E9050JB<br />

Pole Mounting Option 2009762-001<br />

Wall Mounting Option 2009763-001<br />

Hose Management Option 2009764-001<br />

Bed Rail Option 2009765-001<br />

Nurse Call 487208CR<br />

NIBP:<br />

Air Hose 12 ft Adult/Pediatric, Screw Connector 107365 E9050LH<br />

Air Hose 24 ft Adult/Pediatric, Screw Connector 107366 E9050LJ<br />

Air Hose 12 ft Neonatal 107368 E9050LK<br />

CUFF Assortment Packs:<br />

CLASSIC-CUF ® Assortment Pack 2692 E2692J<br />

Includes: 1 each: Infant, Child, Small Adult, Adult, Large Adult, Thigh Cuff<br />

CLASSIC-CUF ® Assortment Pack, Neonate 2693 E2693J<br />

Includes: 2 Neo #1, 3 Neo #2, 5 Neo #3, 5 Neo #4, 5 Neo #5<br />

SOFT-CUF ® Assortment Packs: 2695 E2695J<br />

Includes: 1 Infant, 1 Child, 2 Small Adult, 2 Adult, 2 Large Adult,<br />

1 Thigh, 1 Adult Long Cuff<br />

SOFT-CUF ® Assortment, Neonate 2694 E2694J<br />

Includes: 2 Neo #1, 3 Neo #2, 5 Neo #3, 5 Neo #4, 5 Neo #5<br />

DURA-CUF ® Assortment Packs: 2699 E2699J<br />

Includes: 1 each: Infant, Child, Small Adult, Adult, Large Adult, Thigh Cuff<br />

DURA-CUF ® Assortment Pack, Adult 2698 E2698J<br />

Includes: 1 each: Infant, Child, Small Adult, Adult, Large Adult, Thigh Cuff<br />

DURA-CUF ® Assortment Pack, Child 2697 E2697J<br />

Includes: 2 Infant, 3 Child, and 1 Small Adult Cuff<br />

Additional Blood Pressure Cuff Codes are available through: www.gemedical.com<br />

TEMPERATURE:<br />

IVAC* Turbo Temp Oral Temperature Probe, Long Cord 2008774-001<br />

IVAC* Turbo Temp Rectal Temperature Probe, Long Cord 2008775-001<br />

IVAC* Temperature Probe Covers 615118 E9050KK<br />

*IVAC is a trademark of Alaris <strong>Medical</strong> Systems


SPO2:<br />

NELLCOR*:<br />

Pulse Oximeter Cable DOC-10 2008773-001<br />

DuraSensor Adult Oxygen Sensor DS100A<br />

Masimo**:<br />

Adult Reusable Sensor, 1/Bx (NR125) 2009745-001<br />

Cable (PC08) 2009743-001<br />

*NELLCOR is a trademark of Nellcor Puritan Bennett.<br />

**Masimo is a trademark of Masimo Corporation<br />

148


European Representative<br />

GE <strong>Medical</strong> Systems<br />

Information Technologies<br />

GmbH<br />

Postfach 60 02 65<br />

D-79032 Freiburg,<br />

Germany<br />

Tel. +49 761 45 43 - 0<br />

Fax +49 761 45 43 - 233<br />

0086<br />

2009360-001 B

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